Funktionelle Elektrostimulation

Center of Biomedical Engineering and Physics
Medical University of Vienna, Austria
Winfried Mayr Vienna Medical University - Center of Biomedical Engineering & Physics
1
Technological Ressources
Plastics Lab.
Microelectronics
Computer / Microcomputer
Mechanics
CAD/CAM Electronics
2
OUR TEAM – Permanent Staff, Biomedical Engineering

Temporary Staff
University Education:
FES-Walking FES-Implants FES-DDM Sensor-/Actuator- Digital Signal Ph.D.

applications Processing Modeling/Simulation
+ + + + +
PCs, Network, Electronics Co-operations Sensors/ PC-Measurement,
µ-Computer Mechanics Measurement CAD
Sub-University Education:
Ph.D.
EMG-Feedback-FES
Industry collaboration
Mechanical Precision Software Mechanic Electrical Engineer
Engineer Mechanics Engineer Microelectronics
CAD/CAM CAD/CAM
Winfried Mayr, MedUni Wien 1

Co-operation partners
Clinics & Departments, Industriekooperationen:
Vienna Medical Univ. Otto Bock
TU Biomed Med-
Med-El
external Clinics,
Clinics, Insight Instruments
Departments & Rehab Seibersdorf
Centers:
Präzisionsteile GmbH
Wilhelminenspital
Vienna,
Vienna, University of Plansee
Graz, Weißer Hof A, Schott
Bad Häring A, Bad .....
Murnau D, Bad
Wildungen D, Hamburg,
Tübingen, Heidelberg,
Padova,
Padova, Ljubljana,
Moscow,
Moscow, Liverpool, . . .
. . . . . Vienna Medical University - Center of Biomedical Engineering & Physics
Mayr
Winfried
4
Examples for co-operations projects:
EOG for
remote control
Heater for
local hyperdermia
Pruritometer
Tool for gaining
brain samples
diagnostic Force distribution measurement

ERG knee joint endo-prostheses
5
ISEK 2006 - Torino

“From Research to Clinical Practice”
Functional Electrical Stimulation
Basic Research:
- indispensable for clinical application
- explanation of clinical observations
Clinical Research:
- part of Clinical Practice
Clinical Practice -> “Clinical Routine”
- routine component in rehabilitation
6

Cardiac Pacemaker: First Prototyp 1958 – the most successful FES-Product today
7
Auditory prostheses:
Cochlea implants
Visual prostheses:
• epiretinal
• subretinal
• optic nerve
• cortical
8
Practically all FES-applications are based on

NERVE- and NOT on MUSCLE stimulation !
9

FES is a rather coarse tool for activation of very
small and complex nerve structures
Frank Rattay
“Electrical Nerve Stimulation”
10
Stimulations parameters
M-wave
11
Electrodes for
nerve stimulation
12

Vienna epineural elektrode Mechanical stability
Biocompatibility
Electrochemical stability
13
Electrode technology
14
Rules for constructing active implants
All surfaces biomaterials,

biomaterials, smoothly
structured,
structured, no edges
Robust but lightweight
Components and DC- DC-conducting leads in
hermetic case (metal oder ceramics)
ceramics)
Pure metals, no alloys
Preferably welding,
welding, if unavoidable acid-
acid-
free soldering,
soldering, never conductive bonding
Antenna coils inside the case
Long isolation distances
Polymer sealing in Nitrogen atmosphere,
atmosphere,
avoiding bubbles and fast temperature
changes during curing
.....
15

3 Generations of Vienna FES-Implants
Rf-powered 8-channel implant Rf-powered 20-channel implant battery powered 8-channel implant
16
Rf-powered 8-channel State-of-the-art

External supply and control unit 27 MHz Carrier
Display Control switches
Implant
Rechargable battery µ-controller board Antenna coil
Hysol
Covar case
low,5ms
Amplitude-limiter
high,40ms
Antenna coil
Power supply Decoder
Carrier Suppression,5ms
Impulse generator
24 bit Data
RF-link
Current source
Output switch array

Phase Change
Antenna coil DC decoupling capacitors
Electrode connector
RF-link
Stimulus Duration
to a
SECOND IMPLANT
8 stimulation electrodes
Battery powered 8-channel Next generation

Implant
Titanium case
Hysol
Interface box Antenna coil
RS 232
Telemetry circuit
Antenna coil
WG 8602 battery µ-controller
Charge
RF data link pumpe
Current source Amplifier
Output switch array
DC decoupling capacitors
Electrode
Electrode connector connector
Recording
8 stimulation electrodes
electrodes
17
Locomotion pacemaker
Wien, 1983
Vienna, 1983 Montpellier,
Montpellier,
2000
2000
18

Wien, 1983 Montpellier,
Montpellier,
2000
2000
19
Phrenic pacemaker - enormous improvement in quality of life
Vienna / Bad Wildungen, 1984
20
Phrenic pacemaker - enormous improvement in quality of life
Avery / US
Atrotech / Finnland
21

Brindley‘s sacral anterior root stimulator – bladder control
more than 2000 implantations

more than 25 years lifetime
22
What decides about the survival of an FES implant ?
There should be
a need
a smart solution
technology, application, handling sufficient
legal requirements fulfilled
fast reacting support
in application and in case of failure
justification of costs
“unlimited” financial room to move
.....
23
POTENTIAL APPLICATIONS:
a
b Continence (Graciloplasty)
Phrenic pacing
Cardiac support (latissimus)
Hand-/ arm-neuroprosthesis
e
Peroneus-stimulator
c Walking aid
Spinal cord stimulation
- Chronic pain therapy

f
- Treatment of spasticity
- Locomotion
.....
24

What is new and promising ?
2 examples of novel implant applications:
Activation of movement generators
in the SCI
(Milan Dimitrijevic)
Dimitrijevic)
Release of insulin via stimulation of the
autonomic nervous system
(Janez Rozman)
Rozman)
25
FES of Spinal Cord
Movement pattern generators
CPG, LLPG
26
Mimicking brain stem control of the lumbar network
tonic
suprasegmental
drive
spinal cord injury
spinal cord
stimulation
(SCS)
intermittent
phasic
afferent input
27

Methods: Epidural spinal cord stimulation
Cross-section at T12 vertebral level
Vertebral bone Vertebral canal

Spinal cord
Spine
Electrode
Anterior roots
Spinal cord
Posterior roots
Dura mater
Epidural space
Pulse generator
Epidural electrode site
Continuous stimulation
210 µs pulse width
1 – 10 V
2.2 – 100 Hz
28
Non-
Non-patterned spinal cord stimulation induces stepping movements
Electromyographic recording
Spinal cord
Descending Spine
input
Electrode
Complete
spinal cord injury
29
A 10 V, 6 Hz 10 V, 31 Hz
Q 1 mV 0.5 mV
H 1.5 mV 0.5 mV
TA 1 mV 1.5 mV
TS 1.5 mV 0.5 mV
KJA 45° 45°
2s 2s
B 9 V, 30 Hz
Q 2 mV
H 1 mV
TA 1 mV
TS 1 mV
KM 90°
2s
Q 2 mV
Stimulus artifacts 0.05 s
30

Can the LLPG process sensory feedback input to generate
functional EMG patterns?
patterns? Methods
31
Can the LLPG process sensory feedback input to generate

functional EMG patterns?
patterns? Results
32
FES of Autonomic Nervous System
Insulin delivery
33

Experiments in dogs: increase of insulin release
in both
39-electrode cuff
intact and partly
around left vagus
dysfunctioned (alloxan)
biphasic rectangular: pancreas
200µs, 1mA, 20Hz
34
35
surface electrodes surface electrodes
stimulation stimulation stimulation stimulation stimulation stimulation stimulation stimulation

module 1 module 2 modul 3 module 4 module 1 module 2 modul 3 module 4
APPLICATIONS:
EMG- signals
I2C bus
EMG- signals
I2C bus
Leg neural prosthesis
4 channel Peroneus stimulator

surface
stimulator
Remobilisation
I2C bus
Continence therapy
I2C bus
COM-Port
Pain therapy
µP-system
I2C Interface
(HC16)
AD-board Therapy of spasticity
PC
Muscle training in space
Long-term bed rest
Chronic heart insufficiency
Sports
…..
36

37
Technical WP 3
stimulation stimulation stimulation stimulation stimulation stimulation stimulation stimulation

module 1 module 2 modul 3 module 4 module 1 module 2 modul 3 module 4
I2C
Control Unit RS232

RS232
433MHz Wireless
FM LAN
RS232
I2C Interface
38
EMG-triggerte FES-training
Relearning of lost movement functions
after partial lesions
University Clinic for Physical Medicine

and Rehabilitation, MUW
University Clinic for Neurology, AKH
Rehabilitationscenters Weißer Hof and
Stiwell / Medel / Otto Bock
Werner Wicker-Klinik, Bad Wildungen
39

Long-term space flights are associated with
degenerative changes in the neuromuscular system.
Conventional exercising (treadmill, bicycle, expander...) at least 3-4 h per day required to be efficient.
Problems: loss of working time, motivation
40
Alternative FES training: MYOSTIM First time in history application of FES

for muscle training in space
isometric muscle training with low intensity,
Dec.98 – Feb.99 und Feb.99 – Aug.99
6h per day, during routine work
easy to handle equipment:
- electrode trousers (Patent D. Rafolt)
- automized 8 - channel stimulator
in co
- operation with
IBMP Moscow
41
Very positive judgement by both cosmonauts
Clear improvements in the functional tests:

· Test 108, Ergometric locomotion
· Equitest, sensomotoric coordination
Indications of positive effects of FES training

in the neuromuscular tests:
· Tendometry
· Dynamometry
· Reflex test
Histological results, to interprete with reservation:

· Biopsy vom Vastus Lateralis
No in relation to FES interpretable results:

· Bone density measurements
42

Preparation of potential application onboard ISS
Participation in the international
terrestrial isolation study in
Moscow(4 subjects)
23. March 2001

ISS
Terrestrial application:
successful application of the method in French
- russian crew an onboard of MIR
chronic heart insufficiency patients
Co
- operation:
University clinic für Physical Medicine
and Rehabilitation, Vienna
43
NMES-Group (n=17) Control group (n=16)

Age: 59 ± 6 Age: 57 ± 8
BMI: 22,7 ± 3,2 BMI: 25,7 ± 3,9
LVEF: 15,1 ± 3,1 LVEF: 18,1 ± 5,2
NHYA: NHYA:
» II: 4 » II: 4
» III: 10 » III: 9
» IV: 3 » IV: 3
since, weeks: 24 ± 6 since, weeks: 26 ± 5
• all on a waiting list for HTX

• stable medication
• voluntary training not possible
44
FES training parameters
• biphasic rectangular impulses

CV / 0,7ms / 50Hz
• 2 s on / 6 s off
• Intensity: 25 - 30% MVC
• initially 30 min / day

• after 2 weeks increased to 60 min / day
• entire FES training period: 8 weeks
45

Force-Endurance-Test
Stimulation group Control group
310 *
310
* * * *
290 290
270 270
E x tens ion force (N)
Extension force (N)
250 250
230 230
210 210
190 190
170 before 170 before

after after
150 150
0 5 10 15 20 0 5 10 15 20
Minutes Minutes
46
NYHA
NMES-group Control group
• 8 patients + 1 class • 1 patient + 1 class
– 3: IV auf III – 1: IV auf III
– 5: III auf II
• 9 patients unchanged
• 15 patients unchanged
ADL
SCORE
pre
22
post
P<0,0001
20 P=0,3
18
16
14
12
10
NMES Control Maximum: 21
47
Summary:
clearly positive effect of the FES training

– not only in the stimulated muscles
– but also on the general condition of the patient
no side effects !
48

49
50
Population pyramids 1950/2000/2050

male female
0 Ö 85 year
0 Ö 85 year
0 Ö 85 year
51

FES of Denervated Muscles
Direct muscle stimulation
52
Upper Lower
motor neuron lesion motor neuron lesion
Nerve stimulation Muscle stimulation
53
Stimulation parameter – surface electrodes

Nerve stimulation: Muscle stimulation:
Amplitude range Amplitude range
Ö ±100V / Ö ±300mA Ö ±100V / Ö ±300mA
Pulse width (biphasic) Pulse width (biphasic)
typ.
typ. 0.5ms
0.5ms per phase typ. (Ö100ms) per phase
typ. 20ms (Ö
Frequency (fused contr.)
contr.) Frequency (fused contr.)
contr.)
25 Hz 25 Hz
54

55
56
57

Lomo 1985
58
Valencic et. al. 1985
59
FES of the denervated External supply and control unit
posterior cricoarytenoid muscle Display
Rechargable
Control switches
Hysol
Implant
µ-controller board Titanium case

for glottis opening battery
RS 232
in synchrony with inspiration Antenna coil
Modulation/demodulation
Power supply µ-controller
Current source
Amplifier
Output endstage,
channel selector
RF power link
RF data link
DC decoupling capacitors
Antenna Electrode
Electrode connector
connector connector
Dual-channel EMG
stimulation recording
electrodes electrodes
60

Clinical program for FES
of subjects with lower
motor neuron lesion
61
5th Framework programme

„Quality of Life and Management of Living Resources“
„Research relating to persons with disabilities“
„RISE“
„Use of electrical stimulation to restore standing
in paraplegics with long-term
denervated degenerated muscles (DDM)“
62
3 cm
63

per million EU citizens yearly:
• 100 new spinal cord injuries
• 250 rehospitalisations
• 500 outpatient treatments
• 63 % paraplegics
• about 1/3 flaccid paraplegia
64
no adequate rehabilitation method available

• fast degeneration of muscles, skeleton, joints, skin, ...
• frequent secondary diseases
• problems with social and professional integration
65
Objectives of RISE
• New rehabilitation methode -
- transfer to clinical practice
• Technical equipment -
- new product family for biomedical industry
• Adaptation of EU-regulations for FES-devices -
- scientific basis
66

Consortium: Mayr, Vienna (Co-ordinator) Biomedical Engineering
Kern, Vienna Clinical Study
Salmons, Liverpool Rabbit Study
Girsch, Vienna Pig Study
Carraro, Padova Muscle Regeneration
Gruber, Vienna Muscle Histology
Dimitrijevic, Ljubljana Neurology
Gerner, Heidelberg Rehabilitation Clinic
Exner, Hamburg Rehabilitation Clinic
Kaps, Tübingen Rehabilitation Clinic
additional: [Cerrel-Bazo, Vicenca] Rehabilitation Clinic
[Helgason, Iceland] Rehabilitation Clinic
[Protasi, Chieti] Muscle Fibre Structure
Subcontract: Schrei, Klosterneuburg Rehabilitation Centre
Jonas, Bad Häring Rehabilitation Centre
Potulski, Murnau Rehabilitation Centre
Schmidt, Vienna Dermatology
Losert, Vienna Animal Department
Gallasch, Graz Muscle Function
67
68
RISE Project Start Nov. 1, 2001

Kick Off Meeting Jan. 2002 in Vienna
69

Pilot Study on Rabbits
I x t = const.
0,8
0,7
0,6
0,5
[N]
0,4
Amplitude Fmax
0,3 Amplitude Fmax
0,2
0,1
0
0 20 40 60
Pulse width [ms]
Twitch reaction
150
Duration at 50% Fmax
100
[ms]
50
Time to peak
100 ms
0
0 20 40 60
Pulse width [ms]
70
Rabbit Study
NOTEBOOK
TRANSMITTER UNIT
STIMULATOR
ELECTRODES
71
Rabbit model of denervation
Denervated ankle dorsiflexors

(≅ 3 – 14 years in humans)
• 10 - 51 weeks (≅
Physiological properties
• Excitability
• Force generation and kinetics
• Fatigue resistance
Morphological properties
• Weight and CSA
• Morphology
• Fibre areas
• Fibre types
• Electron microscopy
72

Conclusions: rabbit model
Denervation up to 1 year produced:
– Profound muscle and individual fibre atrophy
– Little degeneration / regeneration
– Loss in tetanic force generation
– Poor morphological structure
No evidence of progressive changes; stable between 10

and 51 weeks denervation.
denervation.
Atrophy, NOT degeneration, in denervated rabbit ankle

dorsiflexor muscles.
73
What was achieved

Long-
Long-term rabbit model of denervation established
Selective motor denervation avoided problems of self-
self-harm
Initial plan was to denervate 10, 25 or 40 days
By the end we had denervated up to 357 days!
Safe envelope for stimulation established

Temperature rise under electrodes less than 1 deg C
No damage under electrodes (other than thickened connective tissue)

tissue)
No damage in muscle, even with the most intensive long-

long-term stimulation regimes
74
What was achieved (contd)

Excitability
Did not change after 4 d
Was not improved by stimulation
Size and morphology

Stimulation restored original weight and CSA (~40%
(~40% normal without)
Histological appearance substantially restored
Electron microscopy (not yet liaised on stimulated-
stimulated-denervated)
denervated)
Conclusions
Any changes in excitability are not at cellular level, or are dependent
dependent on more atrophy
or degeneration than we saw
Changes in SR and T-
T-system suggest loss of E-
E-C coupling
75

Tension-
Tension-generating capacity
Stimulation increased tetanic tension from ~27% to ~49% of normal
Force recovery not commensurate with recovery in weight and CSA
Contractile speed
Time to peak twitch, half-
half-relaxation and speed of shortening all much slower (like
soleus!)
soleus!)
Stimulation did not alter this
Conclusions
Slowness and loss of tetanic tension could be due to loss of E-
E-C coupling
Disadvantage: reduction in power available from muscle
Advantage: fusion achievable at a lower frequency
76

Endurance
Denervation increases mitochondria (NADH-
(NADH-TR, EM)
But muscles, if anything, MORE susceptible to fatigue
Fatigue resistance NOT improved by stimulation—
stimulation—worse with 40 Hz patterns!
Lack of degeneration
Major difference between rabbit (motor branches) and rat (whole sciatic)
Could be species or procedural difference
Intact muscles maintain vascular pumping, may avoid damage due to
to venous
congestion
Conclusions
Stimulation does not improve endurance; may make it worse
Rabbit is a GOOD model of human muscle at 1-
1-2 years post-
post-injury
Rat may be a good model of degenerative changes at longer periods
periods
77
Pig Study
Transformation of results from the rabbit study

Testing of patient equipment
78

PIG MODEL
surgical model for chronic denervation:

denervation:
isolated transsection and resection
of TA and EDL motor branch 79
weeks
0 10 20 30 40 50 60 70 80 90 100 110
0
4
pigs
80
PIG EXPERIMENTS
Technical setup
for invasive investigation:
investigation:
Surgical exposure of TA and EDL
Direct needle EMG

Intramuscular stimulation
to evaluate
ELECTROPHYSIOLOGICAL PARAMETERS
BIOPSIES for histochemical investigation

81

Weight & Handling Problems
Bodyweight:
time of denervation mean 29 kg
now
R 1 - 5 mean age 103 weeks 105kg
R 6 - 9 mean age 76 weeks 98kg 82
PIG EXPERIMENTS
FES
R2 since 29.08.05
R5 since 05.12.05
83
R1 44 weeks denervated EDL
muscle 73%
fat, connective tissue 27%
84

R1 67 weeks denervated EDL
muscle 25%
fat, connective tissue 75%
85
Electrode arrangement
A... monopolar stimulation needle
C B... stimulation reference
C... concentric EMG-needle
B
A
Measurement setup:
Benchstimulator
DAQ – PC-Card with preamplifier
oszilloscope
86
87

R1 EDL den
li EDL 151204_44w li EDL 230205_51w li EDL 200405_67w li EDL 080805_83w
100
90
80
70
60
Amplitude/V
50
40
30
20
83w
10
67w
0
51w
0 10 20 30 49w
40 50
Pulsbreite/ms
88
49w 51w 89w
EMG-signa
not found
3V/0.1ms; D:22mm 3V/0.1ms; D:22mm
Latency: 3,6ms Latency: 3.7ms
speed:6,1m/s speed:5,9m/s
R1_EDL li
Winfried Mayr 1-2ms- Center of Biomedical Engineering & Physics

Vienna Medical University 1-2ms
89
Technical WPs
WP 3: Equipment for home-
home-based training
WP 4: Test-
Test- and measurement equipment
90

Patient Study / Technical WP3
91
Required pulse width
initially 120 - 150 ms

after appr. 1 year 30 - 40 ms
shortest pulse width 25 - 35 ms
(Nerve stimulation: 0.2 – 2ms)
t Peak amplitude
+/- 80 V +/- 250 mA
92
Technical WP 3
93

94
Patient Study / Technical Workpackage 4 Kon

trac
tion
Transversal muscle stiffness

Force
FES 3.5
2.5
Force 2
Agonist Displacement 1.5
0.5
0
0 2 4 6 8 10 12 14 16
Displacement
Antagonist
0.2
Tendometry 0.15
0.1
F
Problem of 0.05
Co-contraction -0.05
t
50 100 150 200 250 300 350 400
Oscillation Tonometry
no stimulatin
With stimulation
Mucle Stiffness
& Viscosity t
a mobile and a stationary system
96

no stimulation weak stimulation
Piendl
2,0
1,8
1,6
1,4
1,2
Frequenz
1,0
Daempfung
0,8
0,6
0,4
0,2
0,0
0 50 60 70 80 90 99 97
Stimulation in % of 80V
Leg responses while FES amplitude was increased
98
Pendulum test
Modeling and estimated parameters
pendulum T... joint torque
test
data
model C...joint stiffness
for
pendular
leg D...viscous moment
motion
limb
geometrical
data J...moment of inertia
CG... gravity spring
&+ D ⋅ ϕ&+ mgL ⋅ sin(ϕ ) + C ⋅ ϕ = 0 with mgL sin(ϕ ) = CG

J ϕ&
99

FES-induced elastic moment [%]
700 109-7.7y
105-7.5y
116 Ness 301-6.5 y

600
112-6.2y
117-6.2y
500 206-5.5y
FES-induced elastic moment [%]
104-4.1y
110 Skul
106-3.5y
400
108-3.3y
111 Pien 119-3.3y
300 111-1.8y
117 Lan 113-1.7y
205 Bär 207-15m
200
118-13m
206 Böt
110-11m
100 119 Thö 116-10m
114-10m
0 120-10m
0 8 16 24 32 40 48 56 64 72 80 115-10m
205-9m
-100 201-9m
stimulation [V] mean
100
Vergleich:
Änderung des Parameters D
Beispiel: Patient 7,3 Jahre denerviert Beispiel: Patient 1,5 Jahre denerviert
0,14 2,50
vor dem Training vor dem Training
Änderung von D in Nms
Änderung von D in Nms
0,12 nach 1 Jahr Training nach 1 Jahr Training

2,00
0,10
0,08 1,50
0,06
1,00
0,04
0,02
0,50
0,00
0,00
0 8 16 24 32 40 48 56 64 72 80
0 8 16 24 32 40 48 56 64 72 80
Stimulationsamplitude in V
Stimulationsam plitude in V
101
0.2
0.15
F 0.1
0.05
t
-0.05
50 100 150 200 250 300 350 400
Time to peak (TTP) Half relaxation time (HRT) El.mech. delay
Rot:
pre FES
Blau:
1 Jahr FES
TTP, HRT und El.Mech.Delay bei verschiedenen Pulsbreiten

(1, 5, 10, 20, 40, 80, 120, 160ms)
Kein Balken bedeutet: kein Twitch detektierbar

Mit FES ist die Detektionsschwelle von 40ms auf 20ms gesunken.
102

Single fiber recordings / measurement setup
103
Analysis of muscle fibre conduction velocity

(MFCV)
first pos. spike > 50µV
(5.76 ms)
last pos. spike (8.22 ms)
mean latency of all recorded
spikes > 50µV (7.10 ms)
distance betw.
betw. electrodes
32 mm
max. MFCV = 5.6 ms-1

min. MFCV = 3.9 ms-1
mean MFCV = 4.5 ms-1
104
Double pulse stimulation of

denervated muscle
105

RISE Pat. 108 after 1st and 2nd year of FES
ISI = 6 ms; MFCV = 1.85 m/s ISI = 3 ms; MFCV = 4.12 m/s
106
RISE Pat. 119 before and after 1 year of FES
MFCV = 0.98 m/s; ISI = 8 ms MFCV = 1.83 m/s; ISI = 3 ms
107
CT scans every 10 cm
trochanter
0 cm
10 cm
20 cm
30 cm
40 cm
108

Planimetry
Cross Sectional Area (cm²) and Density (HU)
8.7a denervated 1.7a dendervated

cross sectional area = ??? cross sectional area = 50.17 cm²
mean density = 30 HU
109
A.B. # 18 ( 205 ) Cross section right thigh at 20 &

0.8y denervated
30cm
0y 1y 2.5y stimulation
20cm
30cm
110
111

H.T. # 36 ( 119 ) Cross section right thigh at 20 &
3.2y denervated
30cm
0y 1.1y 1.6y stimulation
20cm
30cm
112
113
K.L. # 24 ( 109 ) Cross section right thigh at 20 &

7.7y denervated
30cm
0y 1.3y 2.5y stimulation
20cm
30cm
114

115
Biopsies
116
Long-term Denervated Human Muscle

Lower Motor Neuron Lesion
Prof. Ugo Carraro - Applied Myology Lab - Padova – ugo.carraro@unipd.it
0.9-y [110 (26-5)] 4.0-y [104 (20-5)]
1.9-y [111 (28-5)] 8.7-y [103 (14-1)]

117

Long-term Lower Motor Neuron Lesion
FES Training of Denervated Human Muscle
From: Kern H et al J Rehabil

Res Dev 2005
Prof. Ugo Carraro - Applied
Myology Lab - Padova –
ugo.carraro@unipd.it
118
Myofiber Lower
Regeneration Motor
in Long-term Neuron
Lesion
Denervated
Human
Muscle
MHC-emb+
Regenerating
Myofibers
From: Kern H et al J. Neuropathl Exp Neurol

FES -
2004; 63: 919-931.
Prof. Ugo Carraro - Applied Myology Lab -
Padova – ugo.carraro@unipd.it
Training
119
Effect of FES Training on Myofiber Size of

FES Trained Normal Peripheral Denervation Central Lesion

70
60
Minimum Diameter (µm)
50
40
30
20
10
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
De ne rvation (ye ar)
14th ECPRM - Wien, May 15, 2004 Prof. Ugo Carraro - Applied Myology Lab - Padova – ugo.carraro@unipd.it
120

Muscle excitability
Ca++ release
- t – tubulus (1)
- sarcoplasmatic reticulum (2)
- triad (3)
3
1
2
121
15-
15-month Denervated Human Quadriceps Muscle
A, Severe atrophic fiber. B, a triad in normally innervated muscle. C-D, following long-term
denervation the frequency of ECC units decreases and the morphology changes
dramatically: Many junctions appear to be dyspedic (i.e. they lack RyRs).
Ugo Carraro, Applied Myology Lab, University of Padova
122

Lower Motor Neuron Lesion
Conclusions
1. Human skeletal muscle undergoes three phases during long-term
denervation:
i) Atrophy; ii) Lipodystrophy; iii) Fibrosis,
2. Myofibers survive denervation much longer than generally accepted
(years)
3. After permanent lower-motoneuron lesion repeated cycles of myofiber
death/regeneration contribute to long-term skeletal muscle tissue
persistence
4. Regenerated myofibers have higher excitability and strength than long-
term denervated myofibers
5. Long-term FES training reverts severe denervation atrophy and
maintains trophism of regenerated myofibers
Prof. Ugo Carraro - Applied Myology Lab - Padova – ugo.carraro@unipd.it
123

Patient Study
Pre- Clinical Begin of
selection Evaluation study September 03 May 04 End of study
Wilhelminenspital 15 12 8 2 3 4
Weißer Hof 13 8 5 1 2 3
Bad Häring 13 8 5 1 2 3
Murnau 13 8 5 2 5 3
Heidelberg 13 8 5 3 4 3
Hamburg 13 8 5 0 2 3
Tübingen 13 8 5 1 1 3
Vicenza 1 2
Island 2 3
Piacenza/Lotta 1 1
Patienten 93 60 38 14 25 22
gesamt
124
Patient Study
28 Patients with traumatic fracture between
Th5 und L1 11
10
(9 Th11, 13 Th12) 9
8
num b er of p atien ts
7
23 men 6
∅ 36 a 5
∅ 4.9 a denervated 3
5 women 1
∅ 43 a
0
up to 1,5 2 to 5 6 to 10 11 to 20 20 +
years of denervation
∅ 5.8 a denervated
125
126

127
additional Rat Study
x 40
A B
x 4500
128
Simulation of FES
field distribution in the thigh muscle fiber
tubular openings
extra cellular
intra cellular
myofibrills
sarkolem m a
transversal tubulus sarcomere

longitudinal tubulus
AP-Excitation and Propagation
129

Colour-
Colour-coded T2-
T2-maps of human
skeletal muscle before (left) and
after (right) short-
short-term FES.
130
RISE Plenary Meeting - Iceland June 2005
End of RISE - May 31, 2006

131
9th VIENNA INTERNATIONAL WORKSHOP on

FUNCTIONAL ELECTRICAL STIMULATION
Basics, Technology, Application
19.Sept. - 22. Sept. 2007
http://2007.fesworkshop.org/
The conference location is in one the most

lovely regions of Austria named "Wachau",
in the city of Krems/Danube 132

9th VIENNA INTERNATIONAL WORKSHOP on
FUNCTIONAL ELECTRICAL STIMULATION
19.Sept. - 22. Sept. 2007
Special Topics
1. FES of denervated muscles
2. Spinal cord stimulation (CPG, LLPG)
3. Stimulation of autonomic nervous system
•Insulin delivery
•Blood Pressure
4. Battery powered FES implants
Further Main Topics

5. Neuromuscular physiology 7. Application
•Nerve and muscle: metabolism, fatigue, plasticity •Diaphragm
•Histology •Bladder, pelvic floor, graciloplasty
•Impulse pattern, management •Skeletal muscles for cardiac assist,
•Biomechanics cardiomyoplasty, heart
•Simulation, modeling •Upper and lower extremities
6. Technology of external devices and implants (hemi-, para-, tetraplegia)
•Electronics, microelectronics •Cochlear prosthesis, eye, vocal cord
•Microprocessor control •Pain, spasticity
•Software •Rehabilitation strategies
•Sensors, closed loop control •Other methods
•Biomaterials, encapsulation 8. Product transfer to the clinic
•Connectors, cables, electrodes •Safety
•Regulatory affairs, quality assurance
133

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Center of Biomedical Engineering and Physics

Medical University of Vienna, Austria

OUR TEAM – Permanent Staff, Biomedical Engineering

FES-Walking FES-Implants FES-DDM Sensor-/Actuator- Digital Signal Ph.D.

Winfried Mayr, MedUni Wien 1

Examples for co-operations projects:

diagnostic Force distribution measurement

ISEK 2006 - Torino

Winfried Mayr, MedUni Wien 2

Practically all FES-applications are based on

Winfried Mayr, MedUni Wien 3

Winfried Mayr, MedUni Wien 4

Rules for constructing active implants

 All surfaces biomaterials,

Winfried Mayr, MedUni Wien 5

Rf-powered 8-channel State-of-the-art

Output switch array

Battery powered 8-channel Next generation

Current source Amplifier

Output switch array

Winfried Mayr, MedUni Wien 6

Phrenic pacemaker - enormous improvement in quality of life

Vienna / Bad Wildungen, 1984

Phrenic pacemaker - enormous improvement in quality of life

Winfried Mayr, MedUni Wien 7

more than 2000 implantations

What decides about the survival of an FES implant ?

 Cardiac support (latissimus)

 Spinal cord stimulation

- Chronic pain therapy

Winfried Mayr, MedUni Wien 8

FES of Spinal Cord

Movement pattern generators

Mimicking brain stem control of the lumbar network

Winfried Mayr, MedUni Wien 9

Cross-section at T12 vertebral level

Vertebral bone Vertebral canal

Epidural electrode site

KJA 45° 45°

Stimulus artifacts 0.05 s

Winfried Mayr, MedUni Wien 10

Can the LLPG process sensory feedback input to generate

FES of Autonomic Nervous System

Winfried Mayr, MedUni Wien 11

surface electrodes surface electrodes

stimulation stimulation stimulation stimulation stimulation stimulation stimulation stimulation

4 channel  Peroneus stimulator

 Long-term bed rest

 Chronic heart insufficiency

Winfried Mayr, MedUni Wien 12

stimulation stimulation stimulation stimulation stimulation stimulation stimulation stimulation

Control Unit RS232

University Clinic for Physical Medicine

Winfried Mayr, MedUni Wien 13

Alternative FES training: MYOSTIM First time in history application of FES

Very positive judgement by both cosmonauts

Clear improvements in the functional tests:

Indications of positive effects of FES training

Histological results, to interprete with reservation:

No in relation to FES interpretable results:

Winfried Mayr, MedUni Wien 14

23. March 2001

NMES-Group (n=17) Control group (n=16)

• all on a waiting list for HTX

All surfaces biomaterials,

Cardiac support (latissimus)

Spinal cord stimulation

4 channel Peroneus stimulator

Long-term bed rest

Chronic heart insufficiency

Denervated ankle dorsiflexors

No evidence of progressive changes; stable between 10

Atrophy, NOT degeneration, in denervated rabbit ankle

Initial plan was to denervate 10, 25 or 40 days

By the end we had denervated up to 357 days!

No damage under electrodes (other than thickened connective tissue)

No damage in muscle, even with the most intensive long-

Transformation of results from the rabbit study