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Stimulation
Neurostar Treatment Device
Patient Introduction
Constipation Headache/
Migraine
Diarrhea
Abnormal
Nausea Ejaculation
Drowsiness Impotence
Insomnia Sweating
Decreased Tremor
Libido
Treatment
Nervous Anxiety Discontinuation
Side Effects
Increased
Appetite Weakness
Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am 3
J Psychiatry; Neuronetics, Inc. (data on file)
The NeuroStar TMS System is indicated for
the treatment of adult patients with Major
Depressive Disorder (MDD) who have failed to
receive satisfactory improvement from one
prior antidepressant medication at or above
the minimal effective dose and duration in the
current episode
Nearly all patients received multiple ineffective
treatment attempts in current episode (range: 1 to
23 attempts, avg: 4)
Demitrack & Thase. (2009) Psychopharm Bull
Adapted from: Practice Guideline for the Treatment of Patients with Major
5 Depressive Disorder, 3rd Edition, APA (2010)
6
anterior
prefrontal cingulate
cortex cortex
striatu
m
HIGH hypothalamus
In MDD, some
thalamus
areas of the
brain are
Neural
Activity hypoactive and
others are
brainstem
neurotransmitter
hyperactive.
amygdala centers
LOW
hippocampus
concentration
pleasure/ psychomotor fatigue
interests (physical)
pleasure/interests
psychomotor When there is
fatigue
monoamine an appropriate
Monoamine
(mental) sleep are
Regions implicated in MDD
neurotransmitter amount ofis
dysfunction
guilt appetite
connected to the brainstem via
projections monoamine
linked to MDD
suicidality monoaminergic circuits
worthlessness neurotransmitter
Malfunctioning
activity,
mood
circuits lead
neuronal to
activity
specific
throughout the
guilt symptoms
brain functions
suicidality normally.
worthlessness
mood
Induced electric
currents stimulate
the firing of nearby
neurons, causing the
release of
neurotransmitters
and clinical effects.
Faraday (1839) Experimental Research in Electricity. Vol 1; Barker 9(1991) J Clin Neurophysiol; Barker (1985) Lancet
Depolarization of neurons in
the DLPFC causes local
neurotransmitter release
These effects
Dorsolateral
are associated
prefrontal
cortex with
Anterior
improvements
cingulate
cortexin depressive
Kito (2008) J Neuropsychiatry Clin Neurosci
symptoms
Depolarization of pyramidal
neurons in the DLPFC also Activation of deeper brain
causes neurotransmitter release neurons then exerts secondary
in deeper brain neurons effects on remaining portions of
targeted mood circuits
L R
TMS Coil
L R
13
No systemic side effects
No adverse effect on cognition
Most common adverse event associated with
treatment was scalp pain or discomfort
< 5% of patients discontinued due to adverse events
No seizures with TMS during clinical studies
(over 10,000 treatments)
Six seizures reported with TMS in post-marketing period
(estimated risk of seizure < 0.1% per acute treatment course)
Long term safety demonstrated in 6 months
follow-up
Major Findings:
N=301 patients (ATHF 1 thru 4), Clinically meaningful effect size = 0.52
23 sites (in ATHF = 1 population)
22.1% reduction in MADRS total In open label extension study, 1 in 2
score with active NeuroStar TMS patients responded, 1 in 3 patients
vs 9.1% on sham at 4 weeks (in achieved remission at 6 weeks
ATHF = 1 population) Safety confirmed in 6 month follow-up
Major Findings:
NIMH-funded, independent of industry 30% of patients achieved
N=190 patients, 4 premier academic sites remission in open-label
Primary outcome measure: extension phase
% Remission - Active 15% vs Sham 4% (P = Excellent safety, nearly 90% of
0.015); Odds Ratio of achieving remission:
patients adherent to acute
4.2 (95%CI, 1.3-13.2)
phase treatment course