Codigos Sagrados Orden Alfabetico

1.
4.3.6
PROTOCOL
FOR
Repetitive
TRANSCRANIAL MAGNETIC STIMULATION (rTMS)
and
Repetitive
SACRAL MAGNETIC STIMULATION (rSMS)
TREATMENT CENTRE
NORTHAMPTONSHIRE HEALTHCARE
FOUNDATION TRUST
(NHFT)
Treatment Centre Berrywood 1 of 51 Review Date December 2018

NHFT Policy number CLPr020
Date approved by Trust Policy Board
Review date December 2018
Implementation date
Director responsible for monitoring and Medical Director
reviewing policy
Freedom of information category Policies

TABLE OF CONTENTS
PAGE
1.0 DOCUMENT CONTROL AND ASSURANCE SUMMARY 5
Glossary of Terms 6
2.0 INTRODUCTION 7
2.1 Background Information on rTMS and rSMS 7
2.2 Integrated Care Pathway for rTMS and rSMS 9
3.0 STAFFING 10
3.1 Consultant Psychiatrist 10
3.2 Junior Doctor 10
3.3 Nursing 10
3.4 Nurse Training 11
3.5 General Staffing Issues 12
3.6 Learners 12
4.0 PATIENT SELECTION AND CONSENT FOR rTMS 14

4.1 Obtaining Consent 14
4.2 The patient who is capable of giving valid consent to rTMS 15
4.2.1 Who may obtain consent? 15
4.2.2 The Process of Consent 15
4.2.3 Consent forms 16
4.2.4 Patients who are detained or do not have capacity
to consent 16
4.2.5 Additional criteria which exclude the patient from
this treatment option 17
4.2.6 Action to be followed for patients who meet the
exclusion criteria 17
4.2.7 Criteria under which the patient will be eligible for
inclusion 17
4.3 Provide appropriate patient information 18
4.3.1 Patient information 18
4.3.2 Written information 18
5.0 Drug treatment during and after a course of rTMS 20

5.1 Pregnancy 21

6.0 Preparation of the patient for rTMS 21
6.1 Inpatients 21
6.2 Outpatients 21
6.3 Referring team responsibilities 21
6.4 Patient preparation Inpatients / Outpatients 22
7.0 Motor Threshold and Treatment Procedure 24
7.1 The Administration of rTMS 24

7.2 Identified Risks 24
7.3 Motor Threshold 24
7.4 Pulse width and stimulator magnetic field output 25
7.5 Placement of the treatment coil 26
7.5.1 The machine settings for treatment with Magstim Rapid Plus / plus 1 / 26
and the FDA protocol (2011)
7.5.1a Other protocols for TDR 31
7.5.1b rTMS for Anorexia 32
7.5.1c rTMS for Cocaine Addiction 32
7.5.1d rSMS for Nocturnal Enuresis 33
7.5.2 The Magstim Coils 33
7.5.3 Preparation and Connection 33
7.5.4 The Magstim D70 Coil 33
7.5.5 The Magstim Double 70mm Air Film Coil 33
7.5.6 Coil Set Up 34
7.5.7 Coil Disconnection 34
8.0 The Treatment Process 34

8.1 Referral Process 34
8.2 rTMS preparation 35
8.2.1 Equipment 35
8.2.2 Patient preparation and treatment 36
8.2.3 Consequent treatments 36
8.3 Monitoring of treatment response to rTMS 37
8.4 Follow up 37
8.5 Decision to discontinue rTMS 38
8.6 Medical Emergencies 38

9.0 Appendices / Diagrams
Appendix 1 – rTMS Patient Screening Form 39
Appendix 2 – Excerpts from the Magstim Operating Manual (2011) 40
Appendix 3 – Equality Impact Assessment 41
Diagram 1 – Sites of Stimulation 24

Policy Title Protocol for repetitive Transcranial
Magnetic Stimulation (rTMS)
Treatment Centre Northamptonshire
Healthcare Foundation Trust (NHFT)
Status: - New or Review New
Policy Committee approved Clinical Policies Committee Trust Board

Date, Comments and areas of consideration
Policy Board ratified
Areas / patient groups affected by the policy Patients receiving rTMS/ clinical staff
Policy Development group members Dr O’Neill-Kerr
(All Job Roles and Service Area) Dr Millward
J Cornish RN
J Vaughan RN
Consultation process Trust Board

(Length of consultation and those consulted - Job Equality and Diversity Team
Role and Service Area) Multidisciplinary Team (MDT)
Dr Palanyappan
Dr Sudheer
Nottingham Neurosciences Unit
Dr Rosedale
Columbia University New York
Dylan Thomas, Jo Durrant; Magstim
Public and Patient involvement/Consultation if

necessary
Meets National criteria with regard to
NHSLA No standard specific to rTMS
NICE Yes: Interventional procedure guidance

242 (Nov 2007)
NICE Update : IPG 542 (2015)
NSF Yes
Mental Health Act Mental capacity Act (2005)
Equality impact Assessment Yes

Race Impact Assessment Completed
How will the effectiveness of this policy be monitored Monthly reports to Medical Director
Ongoing audit of efficacy
Stand-alone audits.
Training Needs Analysis Yes included within this document

Further comments to consider at the time of CG90 (2009) and QS8 (2011) depression
ratification for this policy (i.e. National policy, in Adults.
Legislation and consultation across SHA). The Depression Evidence update 13
(April 2012)
If this policy requires Trust Board ratification please Peer approval from an external
provide specific details of requirements Consultant Psychiatrist
1.0 Document Control and Assurance Summary
NB The name Committee refers to all committees within the Trust where policies are
developed reviewed and approved.
The word policy is used generically for a policy, guideline or protocol, which requires
consultation and approval prior to dissemination for use throughout the Trust.

It is the responsibility of the person accessing this protocol to ensure that the most up to date
version is used.
Glossary of Terms
APB Abductor Pollus Brevis

BDI Becks Depression Inventory
CATSS Crisis and Telephone Support Service
CGI Clinical Global Impression
cms Centimetres
CALS Community Access to Language Service
CPD Continuing Professional Development
CVA Cerebral vascular accident
DLPFC Dorsolateral Prefrontal Cortex
DoH Department of Health
Systm Patient’s electronic notes
One
EMG Electromyography
FDA Food and Drug Administration
GP General Practitioner
HAM-D Hamilton Depression Rating Scale
ICP Integrated Care Pathway
ILS Intermediate Life Support
MEP Motor Evoked Potential
MKCHS Milton Keynes Community Healthcare Service
MHT Mental Health Team
MRI Magnetic Resonance Imaging
MT Motor Threshold
NICE National Institute of Clinical Excellence
NHFT Northampton Healthcare Foundation Trust
NMC Nursing and Midwifery Council
PGD Patient Group Directive
RC Responsible Clinician
RN Registered Nurse
rTMS Repetitive Transcranial Magnetic Stimulation
rSMS Repetitive Sacral magnetic Stimulation
Sagepay Web-based platform for interface between patients / clinicians
SAH St Andrew’s Healthcare
SLA Service Level Agreement
SMT Standard Motor Threshold
UI Universal Interface
UoN University of Northampton

2.0 Introduction.
The purpose of this protocol is to provide clear guidelines to facilitate and provide excellent
service provision based on current evidence and best practice for repetitive Transcranial
Magnetic Stimulation (rTMS) and repetitive Sacral Magnetic Stimulation (rSMS). However,
ongoing research and new developments within rTMS and rSMS may necessitate
amendment of this document and working protocols.
The Treatment Centre at Berrywood Hospital, Northampton will provide a countywide rTMS /
rSMS service. Contact details for the department are the Treatment Centre, Berrywood
Hospital, and Tel: 01604 865590/91, email: treatment.centre@nhft.nhs.uk. The service will
cover the population of Northamptonshire and is accessible to all referred patients including
private patients who are informal and capable of giving consent. Provision will also be made
through a Service Level Agreement (SLA) to provide a service for informal consenting
patients to St Andrews Healthcare (SAH), Northampton and Milton Keynes Community
Healthcare Service (MKCHS) (for specific Inclusion / exclusion criteria refer to Section 4).
The rTMS / rSMS clinic is available five days a week (Mon-Fri) and in exceptional
circumstances evenings and weekends. Provision for rTMS/ rSMS is limited on Bank
Holidays. There is capacity to treat a maximum of 8 patients per day and occasionally for
treatments there may be a waiting list.
This protocol has been developed by the core rTMS team to standardise rTMS practice
across NHFT. It takes account of the Food and Drug Administration (FDA) Protocol for
rTMS, the Nottingham Neurosciences Unit research protocol, the NICE Interventional
Procedure Guidance 242 (2007) and update IPG 542 (2015), CG 90 Depression in adults
(2009), QS8 (2011), the Depression Evidence update 13 (2012) and guidelines for the use of
Magstim Rapid Plus (Magstim, 2011) and Air Film Coil (Magstim, 2009) . Nursing evidence
utilised includes the Nursing and Midwifery Council (NMC) (2001) Standards for Specialist
Education and Practice (2001); Record Keeping: Guidance for Nurses and Midwives (NMC,
2016); The Code, Standards of conduct, performance and ethics for nurses and midwives
(NMC, 2016).
The rTMS clinic uses the Magstim Rapid2 Plus1 with a Magstim D70 and double 70mm air
film coil, this protocol refers exclusively to this machine and this coil.
2.1 Background Information on rTMS

rTMS is a non-invasive treatment with magnetic stimulation applied to target areas in the
brain. The treatment utilises a technique that uses powerful focussed magnetic field pulses
to stimulate the neurons of the brain.
An rTMS device has a stimulation unit that generates strong electrical current pulses (within
NHFT this is a Magstim Rapid Plus). The stimulation unit is connected to an electromagnet
called a coil. Electric currents run through the coil, and are converted into magnetic field
pulses that are similar to those in a Magnetic Resonance Imaging (MRI) scanner, but
focussed into a very small area. These magnetic pulses are applied to the head in rTMS
treatment. (rTMS stimulates the brain with a magnetic field, as opposed to a direct electrical
current, as is used in ECT).
When the coil is placed against the head, the magnetic field pulses pass through the skull to
stimulate the area of the brain that lies directly underneath. When the coil is applied to the
left dorsolateral pre-frontal cortex (LDLPFC) which is a key node in the cognitive control
centre, the magnetic pulses of rTMS excite the neurons causing them to fire tiny electrical
discharges that neurons use to communicate with one another. Billions of neurons make up
the brain and are connected together in many diverse and complex networks. Neurons
communicate with each other by generating electrical impulses that transfer from neuron to
neuron. These electrical pulses are the building blocks of thoughts and emotions as
observed in the brain. These neurons form ‘neural networks’. Neural networks regulate
feelings, emotional responses and self-reflection. However, in depression; the balanced
relationship between neural networks becomes unbalanced.
High frequency stimulation (10 pulses per second) has an excitatory effect on neural activity.
Over time this strengthens the connections between neurons and increases the activity of
the target brain region. rTMS therefore can help restore balance to neural networks in
depression by targeting the LDLPFC which is typically underactive in depression.
2.2 Background Information on rSMS.
Bedwetting, or nocturnal enuresis, causes distress in children and young adults, as well as
for their parents or caregivers. The causes are not fully understood and there may be both
physiological and psychological components to the condition. Several studies report that
rSMS can reduce the frequency of night time bedwetting and improve quality-of-life for
sufferers.

When the figure 8 air film coil magnetic coil is was placed over the sacral vertebrae in the
lower back pointing upwards midline 5cm above the natal cleft it has a direct effect on
bladder control. 15Hz stimulation intensity produces a contraction of the perineum or inner
aspect of the thigh. Khedr’s (2015) study shows that rSMS increased arousal and / or
enhanced inhibition of neuronal re-uptake of noradrenaline and serotonin. Khedr (2015) also
reported that patients with nocturnal enuresis have pathologically increased excitability and
reduced inhibitory processing in the motor cortex and it is possible that rSMS could affect
these measures as well.
High frequency stimulation applied for 10 seconds has an excitory effect and there is robust
evidence in the literature for the use of rSMS at 15Hz, 10 seconds on and 30 seconds off, for
1500 pulses at 50% (6 minutes) 5 times per week for 2 weeks.
rSMS is potentially a safe, non-invasive treatment for a chronic debilitating condition in

young people for whom there is no other treatment option other than waiting for potential
improvement in young adulthood.

2.2 Integrated Care Pathway Identified need for rTMS / rSMS
for rTMS / rSMS
Consultant determines capacity to consent
Patient has capacity and

refusing treatment rTMS Patient has capacity to consent
/rSMS cannot be given
Refer to the rTMS team on

01604 685590 / 91 (24 hour answer machine) or
email: treatment.centre@nhft.nhs.uk
Written and verbal

Information given to patient / carers
Obtain informed
consent
DOH consent form

completed
Preparation by referring team including medical

history, physical examination, investigations, cognitive
assessments and arrange visit to dept. as required.
rTMS Team patient assessment
rTMS / rSMS prescription
Pre rTMS/ rSMS checklist

Consent withdrawn
rTMS /rSMS Treatment Procedure
Reassess treatment plan
Documentation completed
Consider alternatives
Reassess treatment plan
Next treatment

3.0 Staffing.
The skill mix for each clinic comprises of:

 Lead rTMS Nurses (RN with evidence of study at level 7).
 Nurses (RN Mental Health / general).
 Healthcare Assistants (HCA)
 Lead rTMS Consultant Psychiatrist or Deputy available for telephone advice and 1:1
consultation as required.
3.1 Consultant Psychiatrist.
There is a named Consultant Psychiatrist who leads rTMS. The duties of this post include
initial consultation at point of referral, prescribing the rTMS, attending the rTMS clinic as
required to assess the competencies of the rTMS Nurse. To attend the weekly team
meetings that will be held either at the Treatment centre for advice and updates.
Training, supervision of junior psychiatrists (i.e. junior doctors in training, associate

specialists), Consultants not experienced in rTMS and other members of the Multi-
Disciplinary Team (MDT) will be a pivotal part of this role. However, this may be delegated to
the rTMS Nurse Manager or Deputy Manager if the rTMS Consultant Psychiatrist deems the
nurse competent. Other responsibilities include the development of rTMS treatment
protocols, liaising with and advising other professionals, audit, quality assurance and
facilitating Continuing Professional Development (CPD) for nominated Consultant
Psychiatrists and the rTMS nurses.
It is the responsibility of the lead rTMS Consultant Psychiatrist to ensure that the Deputy
Consultant Psychiatrist and if required other Psychiatrists are sufficiently familiar with current
practice to be able to deputise, as necessary, during periods of absence, sickness and / or
annual leave.
3.2 Junior Doctors.
Junior doctors will have the opportunity to receive induction and training on rTMS. However,
as this is a nurse delivered treatment it will not be a mandatory requirement for junior
doctors.
3.3 Nursing.
There is a Lead rTMS Nurse Manager who has appropriate rTMS, management and clinical
experience who takes overall responsibility for the management of the clinic and care of the

patients. It is the responsibility of the Nurse Manager to ensure that the Deputy Nurse
Manager is sufficiently familiar with current practice to be able to deputise, as necessary,
during periods of absence, sickness and / or annual leave.
Other duties include:

 Ensuring that the rTMS room is properly prepared, organised and maintained;
 Ensuring that the machine functioning and maintenance is checked and recorded at
least yearly by a designated Clinical Engineer;
 Ensuring that the equipment required is well maintained, replaced / updated;
 Ordering and stocking disposable equipment;
 Budgetary management;
 Organisation of skill mix for safe delivery of treatment;
 Audit / reports;
 Training and Development of Staff;
 Supervision of Supervision.
Before each session the rTMS Nurse has overall responsibility for carrying out the following
checks:
 Ensuring that emergency resuscitation equipment is tested and checked;
 Ensuring that the Magstim Rapid2 Plus1 and coils are checked visually;
 Ensuring that the output and electrical safety of the Magstim Rapid2 Plus1 is checked
and recorded;
 The delivery dose is also checked and recorded at each application of rTMS.
3.4 Nurse Training.
 All clinic staff receive NHFT induction and mandatory training;

 There is an expectation that staff will continue with CPD activity;
 rTMS Nurses must undergo the in-house rTMS Training programme as part of induction
to the unit;
 Training for rTMS qualified staff also includes attendance for Immediate Life Support
(ILS) and training in the management of seizures;
 Uptake of appropriate post graduate / external courses relevant to rTMS is encouraged;
 Uptake of the yearly Two Day Magstim Training Course for Nurses is also encouraged,
this is mandatory every two years. However, yearly attendance is advised;
 At least one member of the team must attend each consecutive year.

The rTMS teaching includes:
 The theoretical basis of rTMS;
 The local rTMS protocol;
 A practical demonstration of rTMS administration, by either the Lead Consultant
Psychiatrist or rTMS Nurse;
 An introduction to patient selection and pre assessment;
 An opportunity is given to the rTMS Nurse to observe treatment for at least 3 sessions
prior to supervised administration.
It is the responsibility Lead Consultant Psychiatrists to ensure Nurses meet the standards
required outlined in the NHFT Patient Group Directive (PGD) and NHFT competencies for
rTMS. This can be delegated to the rTMS Nurse Manager or Deputy after the Lead
Consultant Psychiatrist deems the Nurse competent.
3.5 General Staffing Issues.
There is a minimum number of staff in the rTMS clinic to safely meet the needs of the
patients at all times.
 At least one Qualified Registered Nurses (RN) and one competent Health Care Assistant
(HCA) present during rTMS treatment
 The RN should be competent in assessing capacity.
 The RN should be competent in the management of seizure activity.
 Lead rTMS Consultant Psychiatrist/ or Deputy contactable via phone or email.
 There is back-up staff easily available to assist in an emergency situation via Berrywood
Alarm System or (9) 999 Emergency Services.
The training needs of rTMS unit staff are formally assessed (via staff appraisals and
supervision). Staff are encouraged to keep up to date with best practice and recent research.
There is a budget for training related to rTMS
3.6 Learners.
Students / MDT from all disciplines are actively encouraged to attend for a morning session
where learning aims and objectives are agreed. The opportunity to discuss preparation of
the patient for rTMS, the rTMS procedure, post treatment observation and monitoring the
patient is offered.

Patients’ consent will be sought prior to treatment as to whether a student / member of
another MDT may observe the treatment. The patient is under no obligation to agree to this
and their decision will be respected at all times. Students / MDT members are also provided
with an information pack. In order to maintain the patient’s dignity and privacy, students and
members of other MDT’s including Consultants may be advised it is not in the patients best
interests to observe that particular treatment session.
Formal teaching sessions are offered throughout the year particularly aimed at Consultants,
junior doctors, student nurses at University of Northampton (UoN), newly qualified staff or
those who have recently joined the Trust; other teaching can be accessed by ward staff and
link nurses through contact with the Treatment Centre. This can also be accessed by
MKCHS and SAH staff upon request.
For more detailed information on training, supervision and professional deployment for
achieving competency within the rTMS department please email:
Treatment.centre@nhft.nhs.uk

4.0 Patient selection and consent for rTMS / rSMS.
To refer a patient for routine or recovery rTMS contact:

 The Treatment centre: 01604 685590/1 (24 hour answer machine; accessed regularly
throughout the day: Mon-Fri 07.00 – 16.00hrs.
 rTMS Nurse (mobile) via Berrywood reception: 01604 682682
Mon –Fri 07.00 – 17.00.
 Email: treatment.centre@nhft.nhs.uk
Prior to attendance it is a requirement that the referring Mental Health Team (MHT) formally
assesses and document the patient’s mental capacity regarding rTMS. This is to highlight to
the rTMS and referring MHT that the patient has capacity to give informed consent regarding
this treatment option. Only patients who are informal and give informed consent will be
eligible to access this treatment option.
4.1 Obtaining Consent.
All medical procedures, be they therapeutic or investigative, involve consent –that is a

measure of willingness on the part of the patient to undertake the procedure proposed. In
this, rTMS is no different to other therapeutic interventions. However, rTMS has a particular
status within psychiatry that makes specific discussion of issues with regard to consent
necessary as patients must be deemed competent and capable of consent.
rTMS is unusual in that consent obtained is for a course of treatments rather than for an
individual procedure. Additionally the practitioner seeking the consent may not be the person
giving the treatment. The fact that the person receiving treatment has a psychiatric disorder
sufficiently severe for rTMS to be considered raises questions about their capacity; this
makes it particularly important when consent is taken to ensure it is properly obtained and
valid.
It is unlawful and unethical to treat a patient; who is capable of understanding the nature of
any procedure, its purpose and implications, the anticipated benefits and any reasonable
foreseeable adverse rTMS / rSMS, without first explaining it. The patient must then agree.
Even if a patient chooses not to be informed of the full details of their diagnosis and
treatment, they must be given the option of receiving this information and this should be
documented. Guidance on good practice in consent can be found in publications from the
Department of Health (DoH) in England and Wales (2009) and the General Medical Council
(GMC) (2013).

4.2 The patient who is capable of giving valid consent to rTMS / rSMS
4.2.1. Who may obtain Consent?
The referring Consultant Psychiatrist first assesses the patient to determine capacity to
consent. A record is made on Systm One of this assessment. Although UK law makes no
distinction between the validity of written, verbal or even implied consent, it is recommended
in practice to seek the patient’s written consent using the NHFT rTMS / rSMS Consent Form.
Treatment will not be given to consenting patients if this form is not complete, valid and in
date. Written informed consent is then obtained by a Consultant Psychiatrist with adequate
knowledge of the nature and effects of rTMS / rSMS (as determined by the referring
Consultant) and with respect to patient’s rights.
The absence of a written statement of consent may make it difficult to provide evidence that
consent has in fact been given. Since written consent is obtained for the course of treatment
and not for each treatment session, it is important to ensure patients clearly understand that
they can withdraw consent at any time, despite having signed a consent form. They should
also understand how they might inform staff about a change in consent. The confirmation of
continued consent should be verbally checked and documented before each treatment.
4.2.2. The Process of Consent.
Obtaining valid consent should be considered a process rather than an event and it is
necessary for patients to be given an adequate length of time to consider the benefits and
drawbacks of the proposed rTMS / rSMS treatment before making an informed decision.
The decision to prescribe rTMS / rSMS is based on a documented assessment of the risks
and potential benefits to the individual.
 Consent is never obtained through any form of coercion. The law is clear that any form of
coercion would negate the validity of consent.
 At least 24 hours is given to reflect on information before making a decision regarding
consent.
 Consent can be withdrawn at any time.
 A maximum number of treatment sessions in a course are stipulated.
 The patient’s relatives are informed unless confidentiality precludes this.
 Alternative therapies to rTMS / rSMS should be raised and it should be made clear that a
refusal of treatment will not prejudice any further care.

4.2.3. Consent forms.
Consenting patients deemed competent complete the NHFT Consent Form, which complies
with DoH guidelines. The referring Consultant Psychiatrist must determine the patient’s
capacity to consent and make a Consultant Note entry on Systm One (i.e consent obtained
by .............. or appointed deputy with adequate knowledge of rTMS / rSMS and consent).
The Consent Form contains the following information:

 The number of treatment sessions in the course is 20. If this number needs to be
exceeded further consent should be sought and recorded. In addition a new consent
form will require completion. Similarly if there is a break in a series of treatments of more
than 3 weeks, continuation should be regarded as a new course of treatment and further
consent obtained. Again a new consent form will require completion.
 Confirmation that the Healthcare Professional has explained the procedure to the patient:
in particular the intended benefits, side effects and what to do if depressive symptoms
worsen.
 Confirmation that the Healthcare Professional has discussed with the patient what the
procedure is likely to involve: the benefits and risks of any alternative available
treatments (including no treatment) and any particular concerns of the patient.
 A statement from an interpreter, if required.
 A statement which the patient has signed, or which a witness has signed on the
patient’s behalf.
The rTMS NHFT Consent Form and pre rTMS / rSMS checklist contains a section specifying
whether the patient continues to give ongoing consent before each treatment and must be
signed by the rTMS Nurse and patient to confirm ongoing consent. If consent to treatment is
withdrawn, the patients’ rights will be respected and the referring Consultant and rTMS team
informed. This outcome will be documented on the consent form and Systm One with the
recommendation that the referring Consultant Psychiatrist and MDT consider an alternative
treatment option.
4.2.4 Patients who are detained or do not have capacity to consent.

This includes:
 The detained patient who has capacity to consent to treatment.
 The detained patient who is incapable of giving consent to accept or refuse treatment.
 The informal patient who is incapable of giving consent but not refusing treatment
 The informal patient who refuses to give valid consent
 Any patient under the age of 18, whether detained or informal.

Refer to Section 4.2.6 as the above patients do not meet the inclusion criteria for rTMS.
4.2.5 Additional Criteria which exclude the patient from this treatment option.
 Cochlear Implant
 Previous or current history of seizures or epilepsy.
 Actively suicidal.
 Preponderance of anxiety symptoms.
 History of / or potential alcohol withdrawal.
 Current alcohol /stimulant dependence with propensity for toxic withdrawal seizures.
 Major unstable medical disorder.
 Cardiac pacemaker or implanted medication pump.
 Clinically relevant neurological co-morbidity such as brain neoplasm, cerebral vascular
accident (CVA).
 Metals objects in and around the body which cannot be moved.
 Pregnancy.
 HAM-D of 25 or above however if the HAM-D score is above 25 and the patient is
experiencing anhedonia they may be included at the Consultants discretion. Patients with
a HAM-D of above 30 should not be accepted for treatment without further clinical
review.
4.2.6 Action to be followed for patients who meet the exclusion criteria.
 Refer back to the referring Consultant Psychiatrist/ MDT where alternative strategies for
those not suitable for rTMS may be considered.
 This could include antidepressant switches, mood stabilisers, psychology or talking
therapies.
4.2.7 Criteria under which the patient will be eligible for inclusion.
 Adults over the age of 18, however patients over the age of 65 should be considered for
higher dose thresholds, in the region of 70 -75% as studies have shown this group may
need higher doses because of cortical atrophy.
 Gender: both.
 Diagnosis of depressive disorder (DSM IV)
 Diagnosis of treatment resistant depression (TRD).

 Patients may get referred with different diagnosis, for example. patients with Chronic
Fatigue. In Consultation with the referring Consultant and Lead rTMS Consultants a plan
of care would be decided upon.
 Patients able to give informed consent.
 Previous response to ECT but where the patient is unwilling or unable to have ECT.
 Previous response to rTMS .
 Inpatient or outpatient.
 Patients from referring hospitals where an SLA is in place.
 Private patients with medical insurance or self funding.
A GP summary / documentation on Systm One should assist in accessing suitability from a

physical /mental health perspective.
4.3 Provide appropriate patient information.

4. 3.1. Patient information
Patients are provided with appropriate information both verbally and in written formats.
Alternative formats are available as required (i.e. an interpreter, signer, visual, pictorial or
alternative as required which those with other disabilities can use). rTMS / rSMS information
leaflets are available for download from the intranet or hard copies are available directly from
the Treatment Centre.
This information covers:
 The nature of the treatment and a description of the process;
 The purpose and benefits of treatment, including likelihood of success;
 The risks and likelihood of adverse side effects;
 Treatment alternatives and confirmation, that these will be available if patient decides not
to have rTMS / rSMS;
 Information on patient’s rights;
 Advocacy services.
4.3.2. Written information.

A basic ‘Introduction to rTMS / rSMS NHFT leaflet (2014) which explains key information is
given to all patients. This includes:
 What is rTMS / rSMS?
 How does it work?
 How is rTMS / rSMS given?
 How often will I have to attend for treatment?
 What are the risks?

 Treatment alternatives.
 Information on patient’s rights.
 Advocacy services.
 Reference to recent research literature.
 Contact details for the treatment centre.
Information when necessary is translated into languages other than English and in forms,
which people with sight, learning and other disabilities can use. If a person has difficulty
communicating in English (the preferred language is documented on the referral card and
Systm One) then information is provided through an interpreter and this is recorded on
Systm One. Provision for translation is via the Community Access to Language Service
(CALS), ideally relatives should not be used to provide an interpretation service. The patient
is informed about how to obtain additional information including access to independent
advocacy. This is clearly documented in the NHFT ‘Introduction to rTMS /rSMS leaflet.
Clinicians also ask patients what additional information they might need.

5.0 Drug treatment during and after a course of rTMS / rSMS
Patients must be individually assessed prior to and during a course of rTMS / rSMS
regarding current medication regimes, its management and the combination of rTMS / rSMS
and medication by the referring MHT and rTMS team. Any changes must be communicated
to the rTMS Team to ensure continuity of care and to minimise risk.
It is usually necessary to maintain effective oral antidepressant regime during and after the
course of rTMS in order to sustain antidepressant effects beyond the duration of rTMS.
There is no requirement to alter the medication regime on the morning of treatment.
If further advice is required then this must be sought through NHFT Pharmacy department at
the earliest opportunity
5.1 Pregnancy.
A pregnancy test for females of child bearing age who cannot rule out pregnancy should be
undertaken prior to commencing a course of rTMS. If the test is positive or the patient is
trying to become pregnant rTMS cannot be offered as a treatment option when weighing up
the safety / risk / benefit ratio.

6.0 Preparation of the patient for rTMS / rSMS.
If it is identified that a patient has specific communication needs then the referring team will
need to consider the options to facilitate the assessment and preparation for rTMS / rSMS.
This may be in the format of an interpreter, signer or alternative as required (i.e. people with
sight, learning or other disabilities can use). It is expected that patients will be fit to travel to
and from their appointments. However, they may need to consider additional support for
their 1st appointment (i.e. family member, carer, nurse escort) in case of needing support /
help with transportation home.
6.1 Inpatients.
The rTMS Nurses will provide a current rTMS / rSMS pack and relevant information for the
team and patients. The rTMS team are available for advice and guidance throughout.
Prior to the first treatment, a ward visit is undertaken by the rTMS nursing team in order to
liaise with the referring team to complete a pre-assessment and meet the patient / carer to
explain the procedure and answer any questions they may have. If receiving treatment as an
outpatient a pre-assessment will be completed by the treating team prior to first treatment, at
either the referring team base or the Treatment Centre.
Patients/Carers will be offered the opportunity to visit the department also to facilitate any
questions or address any issues raised.
6.2 Outpatients.
An rTMS Outpatient is where an individual attends for treatment from their home or a remote
site. For the purpose of this protocol an Outpatient will also be defined as patients travelling
from St Mary’s Hospital (SMH), SAH, MKCHS or private patients. Factors to consider before
referring patients for outpatient rTMS include:
 Psychiatric risk assessment (e.g. suicide risk);

 Level of compliance with the treatment plan;
 Input of healthcare professionals;
 Social network support;
 Access to IT facilities;
6.3 Referring team responsibilities.
 Informing the Treatment Centre re proposed treatment plan.

 It is the responsibility of the referring team to inform the patient’s General Practitioner
(GP) of the planned course of treatment together with the proposed days of treatment,
in case of any post rTMS complications following discharge or if receiving treatment as
an outpatient. This is to ensure continuity of care.
 The referring team must remain in regular contact with the rTMS Nurse for the duration
of the treatment course.
Prospective rTMS / rSMS patients must receive a formal documented assessment of the
following which should be documented on Systm One:
 An assessment of mental capacity to consent to rTMS;

 A clear statement is included on why rTMS has been prescribed, the purpose and
benefits of treatment, including the likelihood of success;
 An assessment of the risk / benefit balance is considered, other treatment alternatives
and the likelihood of adverse effects;
 An assessment of the patient’s mood / memory is recorded using the Hamilton
Depression Rating Scale (HAM-D), Beck’s Depression Inventory (BDI), Quick Inventory
of Depressive Symptomatology (QIDS) and Clinical Global Impression Scale (CGI).
Confidentiality of Patient Information Code of Conduct for Trust Staff is strictly adhered to.
This is available on the Trust intranet site.
6.4 Patient preparation Inpatient / outpatients.
Patients will be given guidance for preparation on the day of treatment.
 On the night before / morning of treatment, the patient will be required to wash their hair.
The use of gels, conditioner and hairspray is not permitted.
 Ensure relevant documentation is completed within the rTMS / rSMS pack.
 If the patient has been prescribed pain relief for rTMS / rSMS advise the patient to take
medication one hour before treatment.
 Ask the patient to remove all jewellery (including earrings, necklace and rings) before
leaving the ward or home.
 Advise patients that glasses and hearing aids will be removed at the treatment centre
prior to treatment.
 Remind the patient that mobile phones will have to be switched off.

 Advise patients to leave belongings / valuables in the care of ward staff. As an outpatient
your belongings will remain with you.
 Prior to treatment patients will be encouraged to use the toilet.
 Patients will be advised that food and drink are not permitted during treatment.
 Identify and ensure nurse escort (who is known to the patient) is aware of the proposed
treatment in order to optimise support to the patient.
 Find out prior to treatment patient preferences (i.e. iPad, music, TV etc.)
 It may be useful to encourage the use of an informal mood diary to help determine any
changes in mood. This will provide a record of progress, and will be a tool for use with
the treating team and MDT.
If the patient begins to feel more depressed or are having suicidal thoughts, please
inform Consultant Psychiatrist and rTMS team. If an outpatient, advise to utilise Crisis
and Telephone Support Service (CATSS), care co-ordinator, GP or Treatment Centre.

7.0 Motor Threshold and Treatment Procedure.
7.1 The Administration of rTMS.

rTMS is an external device that delivers repetitive pulsed magnetic fields of sufficient
magnitude which produce changes in the neuronal activity region in the brain implicated in
mood regulation (pre-frontal cortex) without seizure activity. As each magnetic pulse passes
through the skull and into the brain, this induces brief activity of the brain cells underlying the
treatment coil.
The frequency and duration of a course of rTMS follows the FDA Protocol (2011) and is
normally administered five days a week for 4-6 weeks. However, this can vary depending on
an individual’s response to treatment. For ‘rescue’ treatments (see Section 9) arrangements
will be dependent upon patient need. As rTMS requires no anaesthesia or sedation it is
suitable both as an Inpatient or Outpatient.
7.2 Identified Risks.

 Failure to identify correct patient population;
 Scalp discomfort, scalp burn, or other adverse effects (scalp stimulation may result in
cutaneous pain and could affect tolerability of rTMS);
 Magnetic field effects on other functioning of other medical devices;
 Hazards associated with electrical equipment;
 Hazards caused by electromagnetic interference and electrostatic discharge hazards;
 Hearing loss;
 Risk of ineffective therapy;
 Seizure (and thus the ability to place the patient in a safe position for seizure
management). For seizure management refer to NHFT seizure management policy.
Children will not be allowed in the treatment room.
7.3 Motor Threshold (MT).

The FDA (2011) determined the motor threshold as the minimum stimulator setting in
standard Motor Threshold Units (SMT) that induces an observable motor response by the
patient in 50% of the applied pulses, usually observed by movement of the thumb. The MT
level is used as a reference point for setting the rTMS intensity, usually expressed as a
multiple of the MT level, for the purpose of this protocol: 120% MT. The origin of TMS is
closely linked to the study of the motor cortex and motor pathways, because there is a very
simple and objective way of measuring the effects of the stimulation in the motor system.
The simplest example is to hold the TMS coil over the hand area of the motor cortex; this will

produce a twitch in the hand muscle represented by this part of the brain. That muscle twitch
can be measured using electromyography (EMG) and is referred to as a motor evoked
potential (MEP).
For the purpose of determining MT for rTMS the abductor pollus brevis (APB) muscle will be
used and because it has a superficial representation in the motor cortex it is easier to trigger
a visual response.
Due to anatomical variations, it is important to find the optimal site of the motor cortex to
elicit a muscle contraction with scalp stimulation.
To find the MT:

 Measure from the nasion to the inion and mark at the halfway point.
 Measure from the tragus to tragus and mark the point at which it crosses your first mark.
Ensure you are measuring both sides of the head from the exact same point.
 This is Cz – the vertex.
 Measure 20% 0f the tragus to tragus distance from Cz vertically towards the patients ear
and make a mark.
 This is C3
Finding the Motor Cortex Hotspot

 Set the stimulator output to 50%
 Place the coil on the C3, flat against the head at a 45% angle to the midline.
 Move the coil in a grid like fashion 1 cm in every direction from C3 until a very good
visual impulse is seen. The point where you elicit the strongest twitch is the motor cortex
hotspot.
 If there is a contraction / twitch the intensity should be decreased in gradients of 2%, and
when it is noted that the intensity of the contractions are weakening the intensity should
be decreased in gradients of 1% until the thumb twitches only slightly. The setting where
the contractions are slight is the MT. There should be a response noted 5 out of 10
times.
 If there is no contraction of the abductor pollus brevis at 70% start again with placement
of the coil until visible contraction of the target muscle is seen.
The Lead rTMS Consultant may also advise that the MT does not need to be determined
and may prescribe the treating dose without the MT being measured. The rTMS Consultant
may also increase or decrease the dose given dependent on clinical presentation.

Prescribing the treatment dose is the responsibility of the prescribing rTMS Consultant only
and not the referring team Consultant.
The nurse administering the rTMS will deliver the dose prescribed by the rTMS Consultant
however from time to time patients may be unable to tolerate the prescribed dose. The rTMS
Consultant has agreed if patients are unable to tolerate the treatment dose this may be
reduced by the nurse by 10%. If this situation arises the nurse will inform the lead rTMS
Consultant and document on SystmOne.
7.4 Pulse width and Stimulator magnetic field output.

 Pulse width: this is defined as the time (duration) from the initial peak to the next peak of
the wave; it is also described as the period of the sinusoidal wave.
 Stimulation Magnetic field output / Volume: Stimulation defines the region of the cortical
tissue within the magnetic field that is above the threshold of cortical stimulation, (i.e. the
three dimensional volume within which the induced electrical field achieves a value
greater than or equal to 80 % of the electrical field at the 2cm reference point). For
example, for a treatment at the 120% MT level, the field at the boundary of the
stimulation volume is equivalent to the MT level and all the tissue within the stimulation
volume is above the MT level).
Diagram 1- Sites of Stimulation.

7.5 Placement of the treatment coil and locating the treatment site – F3.
Once the MT has been established replace the coil with the Double 70mm Air Film Coil, this
is the treatment coil.
 Measure the circumference of the head, above the eyebrows at the front and just above
inion at the back of the head.
 Mark 5% of this measurement, from just above the nasion to the patients left. The mid-
point of this position to C3 is the treatment site - F3, mark this point.
 F3 - This is the correct treatment position for both left and right handedness.
It is possible to use the EEG cap within the department which come in sizes 52, 54, 56, 58
and 60 cm. To use the correct size cap measure the circumference of the head, above the
eyebrows at the front and just above inion at the back of the head and use the cap nearest in
size to the circumference of the head. By using the EEG cap with the F3 placement clearly
marked the person administering the rTMS can save time and ensure accurate placement.
This will also ensure correct placement in satellite clinics.
7.5.1 The machine settings for treatment with the Magstim Rapid Plus
Treatment resistant Depression:
The treatment parameters are standardised to the FDA (2011) protocol, however variations
to this may be prescribed by the Lead rTMS Consultant dependent upon clinical presentation
and side effects.
The set up screen allows the user to set the following adjustable parameters to the desired
values to enable a treatment to be given;
 Power: use the rotary knob to adjust the system power level to120% above MT. (Before
treatment the MT will have been established);
 Frequency: Selecting the frequency will allow the user to set the frequency of the pulses
which should be set to 10 Hertz (Hz);
 Duration; this is the duration of the pulse train which should be set to 4 seconds. On
entering the duration and frequency, the number of pulses is automatically calculated by
the Universal Interface (UI) and displayed;
 Number of pulses: this allows the user to set the number of pulses in a train to between 1
and 60000 in steps of 1. The number of pulses should be 10 pulses per second;
 Wait time: Allows the user to set the wait time between 1 and 540 seconds in 0.1 second
steps. The wait time should be set to 26 seconds;

 No of trains; selection of this allows the user to set the number of times that the specific
train runs to a value between 1 and 999. The number of trains should be set to 75.
FDA (2011) protocol:

 120% above MT;
 10 Hz;
 Pulse duration : 4 seconds;
 10 pulses per second;
 26 seconds off;
 Number of trains 75;
 3000 pulses
 Total actual treatment time: 37.5 minutes.
7.5.1 a
Other protocols for treatment resistant depression which may be prescribed include:
Downer protocol (Theta burst)

• 120% above MT;
• 10 Hz;
• Pulse duration : 5 seconds;
• 10 seconds off;
• 3000 pulses
Hadley et al – double dose protocol

• 120% above MT;
• 10 Hz;
 50 pulses per second
• 10 seconds off (however this may need to be set to 16 seconds by default;
• Number of trains 2 x 60 = 120;
 2 x 300 pulses = 6000 pulses;
• Actual treatment time: 42 minutes.

Intermittent Theta Burst
 80% MT
 50Hz
 Burst frequency 5Hz
 3 pulses
 No of bursts 3
 Cycle time 10 secs
 No of cycles 20
 600 pulses:
Continuous Theta Burst

• 80% MT
• 35Hz
• Burst frequency 5Hz
• 3 pulses
• No of bursts 200
• Cycle time 252.9 secs
• No of cycles 1
• 600 pulses:
7.5.1 b
rTMS for Anorexia (King’s college)

Figure 8 air film coil placed over the dorsolateral prefrontal cortex (DLPFC), rTMS.
 110% above MT;

 10 Hz;
 Pulse duration : 5 seconds;
 X pulses per second;
 55 seconds off;
 Number of trains x
 1000 pulses
 Actual treatment time: 20 minutes.
7.5.1c
rTMS for Cocaine addiction (Terraneo European Neuropsychopharmacology 2016)

Figure 8 air film coil placed over the dorsolateral prefrontal cortex (DLPFC), rTMS daily for 5
days then once a week for 3 weeks.
• 100% MT;
• 15 Hz;
• 60 pulses per second;
• 15 seconds off;
• Number of trains 40;
• 2400 pulses
• Actual treatment time: 13minutes.
7.5.1d rSMS for nocturnal enuresis
Figure 8 air film coil handle pointing upwards midline 5 cm above the natal cleft to produce a
sensation of contraction of the perineum or the inner aspect of the thigh. Treatment is given
5 sessions per week for 2 weeks = 10 treatments.
• Usual dose 50%
• 15Hz
• 10 seconds on
• 30 seconds off
• 15,000 pulses.
• Treatment time 6mins 40 secs
7.5.2 The Magstim Coils.

There is a danger that the coil stand could tilt forward and therefore topple if moved with the
coil attached and the spring arm extended. The spring arm must be strapped to the main
column at all times, using the Velcro strap provided, when not in use. This will prevent the
coil and stand from toppling during inadvertent movement or transportation, and will prevent
damage to the coil and injury to the operator. The spring arm must also be strapped down in
the safe position when moving the coil from the stand, to prevent the stands spring from
bouncing up and striking the operator in the face. When attaching the coil, tuck the spring
arm under the arm to prevent injury to the operator.
The operator must have both the coil and the patient in direct line of sight prior to and during
discharge of the coil.

7.5.3 Preparation and Connection.
Preparation: At the start of each session the operator must check the plastic casing
surrounding the coil for any signs of external damage. If any cracks are visible in the plastic
covers, or there is damage to the handle or cable the coil must not be used as this could
cause a malfunction in the treatment dose.
Connection: There is a locating key on the coil connector, which needs to be aligned with
the corresponding receptor on the stimulator coil socket. It is then possible to rotate the outer
collar of the coil connector in order to lock the coil to the stimulator. Care must be taken to
attach the coil connector to the stimulator correctly as failure to do so can cause damage to
the connector pins and in severe cases internal damage to the coil and the stimulator.
Following an initialisation sequence, the stimulator will recognise the coil and the system will
be ready for use.
7.5.4 The Magstim D70 Coil

The coil has 4 main parts: the coil head, handle, cable and connector. The coil has a figure
of 8 winding in the coil head. There is a copper winding in the coil head, through which
energy from the stimulator is discharged. The current that flows through the winding creates
a magnetic field and a corresponding electrical field. This coil should be used to determine
MT. It is not recommended for use in long treatment cycles.
7.5.5 The Magstim Double 70mm Air Film Coil.
As the coil is intended to be used for 37.5 minutes continuously it must be placed in the
room where it will be used, for 8 hours prior to use. After 8 hours, plug the air film coil into
the Magstim Rapid2 Plus1 and switch on without arming. This starts the cooling fan in the coil
and allows any moisture that may have accumulated in the device to evaporate. After
plugging in the Magstim Double 70mm Air Film Coil into the Magstim Rapid2 Plus1, it is then
essential to wait 1 hour before it is used.
The Magstim Double 70mm Air Film Coil is the treating coil, figure of eight coils are standard
when it comes to rTMS and provides optimal accuracy for many applications. In the
Magstim Double Air Film Coil the winding which generates magnetic impulses is separated
from the patient by using a thin film of continuously refreshed air. The use of an air film
enables the stimulating coil to operate with a relatively hot coil winding, however after
delivering 1 treatment under the FDA (2011) protocol the coil may have warmed up. Keep
the coil plugged in with the Magstim Rapid2 Plus1 switched on for at least 15 minutes after
administering treatment to allow the cooling process to continue.
7.5.6 Coil Set Up.

Connect the coil to the main Magstim Rapid2 Plus1 stimulator. Go through the set up
procedure for the Magstim Rapid2 Plus1. Switch on the Magstim Rapid2 Plus1 and allow the
coil to acclimatise for at least 15 minutes before use. Next, select the FDA (2011) protocol
using the Output power knob, and press the green Run switch on the user interface to arm
the Magstim rapid unit. The system status will display Armed and the instrument will change
to the level displayed on the Power display window.
Triggering the Magstim Rapid2 Plus1 unit causes a magnetic pulse to be delivered by the
Double 70mm Air Film Coil which stimulates the nerves beneath it.
For coil error codes, warnings and precautions refer to Appendix Two.
7.5.7 Coil disconnection.

Coil disconnection should always occur when the Magstim Rapid2 Plus1 unit is in its stopped,
discharged state. If the coil is disconnected from the unit while the unit is charged, the
magnetic stimulator will automatically discharge internally and enter its stopped, discharged
state. Dust and debris can clog the inlet fan, it is recommended that the air film coil may be
cleaned using an isopropyl alcohol-moistened cloth. Always ensure the stimulating coil is
thoroughly dry before use.
8.0 The Treatment Process.
8.1 Referral Process.
Once a referral from a Consultant Psychiatrist is received, a member of the treating team will
contact the patient to complete a pre-assessment. This will include a review of the patient’s
medical / psychiatric history, current diagnosis, patient screening form (See Appendix 1) and
a screen for medical conditions that might affect the patient’s ability to undergo rTMS safely
(Section 4).
If the patient meets the safety requirements for rTMS, the patients Consultant Psychiatrist
will discuss the potential risk, benefits, and answer any questions the patient may have. The
patient can then decide whether they wish to begin a course of treatment. If the patient
decides to agree to a course of rTMS consent can then be taken. A battery of cognitive tests
to measure the severity of your symptoms will be completed to give a baseline score to
enable the treatment team to determine the effectiveness of the treatment. The rTMS pack
will also be completed.
8.2 rTMS Preparation.

8.2.1. Equipment.

Preparation by the nurse for a session of rTMS prior to the patient entering the treatment
room:
 Connect the coil to the Magstim.
 Switch on the Magstim and allow coil to acclimatise for at least 15 minutes.
 Select the stimulating power:120% above MT by using the ‘Output Power Knob’.
 Press the ‘green run’ switch on the UI to arm the Magstim.
 The system status window will display ‘Armed’ and the instrument will charge to the level
displayed on the ‘power display window.
 Press the ‘stop’ switch on the UI, the Magstim will revert to standby and cannot be
triggered until it is re-armed.
8.2.2. Patient preparation and treatment.

The patient will be made aware of the following information to assist in the treatment
process:
 The patient will be fully conscious throughout treatment.
 Before beginning treatment patients are asked to remove any magnetic-sensitive
objects (such as jewellery, credit cards, mobile phones) at least 1 metre from the
magnetic coil.
 Patients are required to wear ear plugs during treatment for comfort and hearing
protection, as rTMS produces a loud clicking sound with each pulse, much like an MRI
machine.
 The patient will still be able to hear but sounds may be muffled.
 When the patient is ready for treatment ask them to sit comfortably in the reclining chair /
trolley. The patient will be asked to stay relatively still.
 The patient will be given an explanation of what to expect.
 The Consultant / nurse will determine the MT as outlined in detail in Section 7.
 Ensure the treatment coil is making contact with the patients head at a 45% angle to the
midline and ask the patient to remain in the same position for the duration of the
treatment.
 The treatment parameters are pre-loaded. Stimulation will be generated at 120% motor
threshold with a pulse sequence of 10 Hz for 4 seconds, followed by 26 second wait.
Treatment will last a total of 37.5 minutes and this is a total of 3,000 pulses.
 Press the start button.
 During the treatment, the patient will hear a series of clicking sounds and will feel a
tapping sensation under the treatment coil, this may feel strange and uncomfortable
(about 50% of patients report this). The sensation is similar to static electricity. Most of

the initial discomfort in rTMS is from nerve stimulation in the face and scalp, however
over the first week, these nerves will get used to this stimulation and the treatment will be
less uncomfortable. Medication prior to or post treatment such as paracetamol can be
helpful to alleviate discomfort.
 During treatment, the nurse / HCA should remain in the room with the patient and
periodically check to ensure the coil is making contact with the patient, this is very
important as the treatment will be ineffective if there is no contact with the scalp.
 During treatment, the nurse / HCA will also monitor the patient in terms of their mood (i.e.
patient’s may report lability of mood).
 After the pulse sequence is completed, move the coil up and away from the patient’s
head and secure to the coil stand with Velcro.
 Ask patient to remove the single use ear plugs.
 Nurse to remove her single use earplugs.
 Assist the patient to stand up.
 Mild scalp tingling and sensitivity during the first hour following treatment may be
reported. Headache or tiredness may also be experienced and approximately 3-5% of
patients may feel faint during the first one or two sessions.
 It has been reported that 0.01%: 1:30000 may have a seizure during brain stimulation
(George 2013).
For most people rTMS does not affect their daily living activity and patients should be able to
do everything they would normally do in a normal day before and after treatment. Please
refer to Appendix Two for Magstim Operating Manual (2011).
8.2.3. Consequent treatments.

 A full course of treatment involves approximately 20- 30 treatments, given on weekdays.
 The referring team remains responsible for the management of the patient.
8.3 Monitoring of treatment response to rTMS.

 Throughout the course of treatment there will be questionnaires to complete to keep
track of the patients mood and subjective experience.
 The patient’s clinical response is monitored and recorded using the BDI, CGI and QIDS
before the 1st treatment, then every 5 treatments and at the end of the course of
treatment.

 The HAM-D is monitored before 1st treatment, after every 10 treatments for a patient
receiving an acute course of rTMS, or at the first and last session for patients receiving
maintenance / rescue rTMS.
 The patient’s clinical status / symptomatic response and subjective experience are
documented.
 Reported treatment side effects are recorded on the side effects form between treatment
sessions.
 Issues of non-compliance with assessment and monitoring are addressed with the
referring team and the rTMS Consultant.
 Patients and carers are offered the opportunity and encouraged to report and discuss
any concerns regarding their rTMS treatment plan.
8.4 Follow up.

 Due to financial restraints the treating team are unable to offer long term follow up.
 Follow up appointments will be arranged by the referring team.
 Adequate psychiatric follow up should be in place for ongoing assessment of patient’s
mental state with a view to early recognition of any relapse of depressive symptoms.
 In the event of relapse after successful treatment, there is the possibility that rescue
treatments / maintenance rTMS may be offered. These additional treatments are usually
effective if rTMS has been successful in the past.
8.5 Decision to discontinue rTMS.

 The prescribing and discontinuation of rTMS is the decision of the patient’s Responsible
Clinician (RC) and should be based on documented clinical improvement as confirmed
by the HAM-D, QIDS, BDI, CGI and clinical opinion / judgement.
 The decision to discontinue rTMS may also take place in the context of discussion with
the rTMS Consultant or because of side effects.
 Discontinuation may also take place because of poor efficacy.
 Or, most importantly, because the patient has withdrawn consent.
The clinical status of a patient should be assessed and treatment should be stopped when
adequate response has been achieved.
8.6 Medical Emergencies

All medical emergencies will be dealt with in line with NHFT policies.

Appendix 1 - rTMS Patient Screening Form
Patient Name:………………………………………….DOB:……………………………..
This should be completed by the patient/patient representative. Please complete the following information:
1. Have you had rTMS before? yes ☐ no☐ 10. Does anyone in your family suffer from yes ☐ no☐
epilepsy?
2. If yes did you have an adverse yes ☐ no☐ 11. Have you ever been a machinist, welder yes ☐ no☐
reaction? or metal worker?
3. Have you ever had a seizure? yes ☐ no☐ 12. Have you ever had a facial injury from yes ☐ no☐
metal / metal removed from your eyes?
4. Have you ever had a stroke? yes ☐ no☐
13. Are you pregnant? yes ☐ no☐
5. Do you have a history of fainting? yes ☐ no☐ NB. Complete pregnancy test for women of
childbearing age
6. Have you ever had a serious head yes ☐ no☐ 14. Last menstrual period? yes ☐ no☐
injury? (Including neurosurgery or
brain related condition or illness that Date:
caused brain injury?)
15. Have you ever had complications from yes ☐ no☐
7. Do you suffer from frequent yes ☐ no☐ an MRI?
headaches?
8. Have you ever had an yes ☐ no☐ 16. How much alcohol do you drink in an
electroencephalogram (EEG)? average week? ………. units
9. Are you taking prescribed yes ☐ no☐ Height: Weight: BMI:

medication or recreational drugs?
Please specify:
Have you ever had or currently have the following:
Aneurysm clips or coils yes ☐ no☐ Wearable cardioverter defibrillator yes ☐ no☐
Cardiac pacemaker or wires yes ☐ no☐ Implanted insulin pump yes ☐ no☐
Internal cardioverter defibrillator (ICD) yes ☐ no☐ Programmable shunt or valve yes ☐ no☐
Carotid or cerebral stents yes ☐ no☐ Hearing aid yes ☐ no☐
Deep brain stimulator yes ☐ no☐ Cervical fixation devices yes ☐ no☐
Metallic devices implanted in your head yes ☐ no☐ Surgical clips, staples or sutures yes ☐ no☐
Dental implants yes ☐ no☐ VeriChip microtransponder yes ☐ no☐
Cochlear implants/ear implants yes ☐ no☐ Wearable monitor (e.g. heart monitor) yes ☐ no☐
CSF (cerebrospinal fluid) shunt yes ☐ no☐ Bone growth stimulator yes ☐ no☐
Eye Implants yes ☐ no☐ Wearable infusion pump yes ☐ no☐
Cardiac stents, filters or metallic valves yes ☐ no☐ Radioactive seeds yes ☐ no☐
Tattoo yes ☐ no☐ Portable glucose monitor yes ☐ no☐
Vagus nerve stimulator (VNS) yes ☐ no☐ Tracheostomy yes ☐ no☐
Blood vessel coil yes ☐ no☐ Medication patch/nicotine patch yes ☐ no☐
Shrapnel, bullets, pellets, BBs, other metal yes ☐ no☐ Other implanted metal or device yes ☐ no☐
fragments If yes please specify …………………..
If you have answered ‘yes’ to any of the above please provide further information:
Signature of patient/patient representative…………………………………………………. Date…..…………

Signature of Consultant Psychiatrist/rTMS Lead Nurse……………………………..…… Date……..……….

Appendix Two – Magstim Operating Manual (2011)

Appendix 3 Equality Impact Assessment
Northamptonshire Healthcare NHS Foundation Trust Equality & Quality Inclusion Analysis Form
Step 1:
Name of ‘Policy or function’ – this may relate to: Protocol

for  Purpose :
repetitive Transcranial Magnetic Stimulation (rTMS) To provide clear guidelines for rTMS, to enable the provision
of an excellent service provision based on current evidence.
 Decisions made, Budget, Business Case, Care Pathways
Commissioning or De-commissioning, Employees, Function,  Aims:
Practices, Procedure, Processes, Procurement, Project,
Programme, Protocols, Service, Service re-design, Strategy, To enable practitioners to deliver rTMS safely and in
Systems accordance with best practice
 Objectives:
To clearly define inclusion and exclusion criteria and
standardise rTMS treatment across NHFT
Step 2:
Test for relevance:
 Will this help to deliver one or more of the aims of the Equality Act 2010?
 Will this have a potential impact on the nine characteristic groups and/or others as described in the guidance?
Does the above ‘Policy’ have any relevance to equality? Yes
Page 45 of 51
This protocol has been developed with consideration given to age, gender, disability, gender
reassignments, sexual orientation, pregnancy and maternity, religion or belief, marriage and civil
partnership or race.
If you have selected yes, please complete section 3-8 below.
Step 3:
Engagement, PSED 1. 2. 3. Please provide details of
involvement and Due regard to: Eliminatin Advancing Fostering evidence considered, service,
consultation g unlawful equality of good workforce, research (national
undertaken discriminat opportunit relation or local), demographic etc.
ion, y between between
Internal √ harassme people people
External √ nt and
victimisati
on
Provide details Equality -ve N +v -ve N +v -ve N +v
Characteristic e e e
Groups
Age √ √ √
Disability √ √ √
Page 46 of 51
Gender √ √ √
Gender √ √ √
Reassignment
Marriage & Civil √ √ √

Partnerships
Pregnancy & √ √ √
Maternity
Race or Ethnicity √ √ √
Religion or Belief √ √ √
Sexual Orientation √ √ √
Other groups (please

list)
Key: +ve = positive impact, -ve = negative impact, N = no impact
Page 47 of 51
Step 4
Engagement, involvement Quality Please provide details of
and consultation evidence considered,
undertaken service, workforce,
research (national or
local), demographic etc.
Internal √
External √ Patient/Programmes -ve N +ve
 Patient Experience – will it: √ Provide an alternative treatment

 Impact on the experience of patients and option
service users?

 Impact on patient choice?
Patient Safety – will it: √ Raise staff awareness

Impact on safety? √ This protocol will improve
knowledge base and practical
Impact on preventable harm?
√ administration of rTMS
Impact on the risk of
healthcare acquired √
infection?
Impact on clinical workforce
capability, care and skills?
Page 48 of 51
 Clinical effectiveness – will Interventional procedure 242
it: (Nov 2007).
√ CG90
Meet evidence based
√ NHS Evidence update 13 (April
practice/NICE guidance?
2012)
Impact on clinical leadership? √
Evaluation report after 1st month
Include systems for
Ongoing audit of safety and
monitoring clinical quality efficacy
supported by good Incident reporting
information?
Page 49 of 51
Step 5:
Have you identified any gaps or potential negative impact from the above? If yes, please state: No
Do you require further information or data to complete the

Do you plan any further engagements?
analysis/actions?
No
No
Any actions to be undertaken (including mitigation) regarding the negative impact:
Action Outcome Lead Date for completion
Any changes made as a result of this assessment? YES  NO 

Please provide brief description of changes
Following information (internal use only)
Step 6: Key individuals

Analysis conducted by: Lead Name: Job Title: Contact Details:
Janie Cornish Treatment centre manager Janie.cornish@nhft.nhs.uk

01604 685591
Other key contributors involved:
Page 50 of 51
Step 7:
Conclusion and/or recommendations:
Step 8:
Date form completed: Clinical/Managerial approval: Job Title/Directorate: Date: Signature:
30 Oct 2014
Does a your Director need to be informed about this Equality Do you need to undertake Date of publication:
Analysis? monitoring/review No
No
Completed copy to be forwarded to equality Team (name)
Page 51 of 51

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1.

Treatment Centre Berrywood 1 of 51 Review Date December 2018

Treatment Centre Berrywood 2 of 51 Review Date December 2018

4.0 PATIENT SELECTION AND CONSENT FOR rTMS 14

5.0 Drug treatment during and after a course of rTMS 20

Treatment Centre Berrywood 3 of 51 Review Date December 2018

7.0 Motor Threshold and Treatment Procedure 24

7.1 The Administration of rTMS 24

8.0 The Treatment Process 34

Treatment Centre Berrywood 4 of 51 Review Date December 2018

Treatment Centre Berrywood 5 of 51 Review Date December 2018

Policy Committee approved Clinical Policies Committee Trust Board

Consultation process Trust Board

Public and Patient involvement/Consultation if

NICE Yes: Interventional procedure guidance

Mental Health Act Mental capacity Act (2005)

Equality impact Assessment Yes

Treatment Centre Berrywood 6 of 51 Review Date December 2018

1.0 Document Control and Assurance Summary

Treatment Centre Berrywood 7 of 51 Review Date December 2018

APB Abductor Pollus Brevis

Treatment Centre Berrywood 8 of 51 Review Date December 2018

2.1 Background Information on rTMS

Treatment Centre Berrywood 9 of 51 Review Date December 2018

2.2 Background Information on rSMS.

Treatment Centre Berrywood 10 of 51 Review Date December 2018

rSMS is potentially a safe, non-invasive treatment for a chronic debilitating condition in

Treatment Centre Berrywood 11 of 51 Review Date December 2018

Consultant determines capacity to consent

Patient has capacity and

Refer to the rTMS team on

Written and verbal

DOH consent form

Preparation by referring team including medical

rTMS Team patient assessment

rTMS / rSMS prescription

Pre rTMS/ rSMS checklist

rTMS /rSMS Treatment Procedure

Reassess treatment plan

Treatment Centre Berrywood 12 of 51 Review Date December 2018

The skill mix for each clinic comprises of:

3.1 Consultant Psychiatrist.

Training, supervision of junior psychiatrists (i.e. junior doctors in training, associate

3.2 Junior Doctors.

Treatment Centre Berrywood 13 of 51 Review Date December 2018

Other duties include:

3.4 Nurse Training.

 All clinic staff receive NHFT induction and mandatory training;

Treatment Centre Berrywood 14 of 51 Review Date December 2018

3.5 General Staffing Issues.

Treatment Centre Berrywood 15 of 51 Review Date December 2018

Treatment Centre Berrywood 16 of 51 Review Date December 2018

To refer a patient for routine or recovery rTMS contact:

4.1 Obtaining Consent.

All medical procedures, be they therapeutic or investigative, involve consent –that is a

Treatment Centre Berrywood 17 of 51 Review Date December 2018

4.2.1. Who may obtain Consent?

4.2.2. The Process of Consent.

Treatment Centre Berrywood 18 of 51 Review Date December 2018

The Consent Form contains the following information:

4.2.4 Patients who are detained or do not have capacity to consent.

Treatment Centre Berrywood 19 of 51 Review Date December 2018

Treatment Centre Berrywood 20 of 51 Review Date December 2018