The primary objective is to assess the effect of tDCS using different electrode configurations on corticomotor excitability in the lower extremities of chronic stroke survivors and healthy subjects. Secondary objectives are (a) to assess the effect…
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Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the relative change in single pulse Motor Evoked
Potential (MEP) of the Tibialis Anterior and Vastus Lateralis at the post
measurements compared to the baseline measurement.
Secondary outcome
Secondary parameters are change in intermuscular coherence between the Vastus
Lateralis and Biceps Femoris, intramuscular coherence of the Tibialis Anterior,
change in propulsion of the paretic leg, change in basic gait parameters,
change in H-reflex of the Soleus, change in reciprocal Ia inhibition of the
soleus and change in D2 inhibition at the post measurements compared to
baseline.Other parameters are the leg portion of the Fugl Meyer score, the 10 m
walk test, the Functional Ambulation Categories and the motricity index
Background summary
Stroke is the leading cause of disability in the western world. About 70% of
the 41.000 individuals who suffer a first-ever stroke annually in the
Netherlands are not able to walk independently after a stroke. Although these
people show some recovery, recovery is often incomplete and the process is long
and labor-intensive.
Recovery is largely dominated by reorganization of surviving brain elements,
also called cortical plasticity. Brain stimulation with weak electric currents,
transcranial direct current stimulation (tDCS), induces plasticity and enhances
motor function. At present, evaluations of this technique only considered arm
function.
Study objective
The primary objective is to assess the effect of tDCS using different electrode
configurations on corticomotor excitability in the lower extremities of chronic
stroke survivors and healthy subjects.
Secondary objectives are (a) to assess the effect of tDCS using different
electrode configurations on coordinated motor output, spinal excitability and
corticomotor drive in the lower extremities of chronic stroke survivors and
healthy subjects, (b) assess the relation between tDCS induced changes in
corticomotor excitability as assessed with TMS and changes in corticomotor
drive as assessed with inter- and intramuscular EMG coherence in healthy
subjects and stroke survivors,(c) assess the relation between the tDCS induced
changes in corticomotor excitability and motor functions of stroke survivors as
assessed with clinical scales.
Study design
This study is a double blind cross-over study. All subjects participate in 3
experimental sessions separated by one week. In all sessions both, subjects and
raters, will be blinded to the applied intervention. The order of the
interventions will be randomized between subjects.
Intervention
In each of the three experimental sessions a different form of stimulation will
be applied being uni-hemisphere anodal stimulation, dual-hemisphere stimulation
or sham (placebo) stimulation. The tDCS will be applied for 10 minutes and
different tests will be performed before (baseline) and after the stimulation
(post) to assess the effects of the stimulation condition.
Study burden and risks
Participants will have to visit the laboratory three times with a minimum of
one week between the different visits. Each of the sessions will take about 3
hours. The applied techniques to modulate and assess corticomotor excitability
are generally well tolerated. Possible side-effects and risks are described in
section 9.4 of the research protocol.
Stroke survivors and the healthy subjects will likely not have any direct
benefit from participation. We do not expect that the stimulation results in
any long lasting effects. It is of importance to conduct this study to know
whether tDCS results in any beneficial short lasting effects. If so, in future
studies we can try to turn these short lasting effects in long lasting effects
by applying tDCS on subsequent days or combine it with motor training. The
tests in healthy subjects are performed to assess and understand the effects of
tDCS when all corticospinal tracts are intact.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
For healthy subjects
- age>18 years;For stroke survivors
- diagnosed with a hemiparesis as the result of a first ever, ischemic stroke
- chronic stage: time since stroke > 6 months
- independent walkers with clear walking impairment
Exclusion criteria
- contraincidation to TMS or tDCS
- other neuromuscular disorder or orhopedic problems
- have a history of cardiac conditions that interfere with physical load
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL34235.044.10 |
| Other | TC=2729 |
| OMON | NL-OMON29069 |