The objective of this study is to determine whether contralesional cTBS treatment modulates the interhemispheric imbalance in excitability or local or transcallosal inhibitory processes in the motor network of a population of stroke patients…
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Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures will be the changes in RMT, IHI, iSP and ICI in
response to contralesional cTBS. The primary outcome measures are described
below:
Secondary outcome
1. The second secondary outcome parameter is the difference in change in RMT,
IHI, iSP and ICI in response to contralesional cTBS treatment between the
subacute phase and the chronic phase after stroke.
2. The first secondary outcome parameter is the difference in RMT, IHI, iSP and
ICI between the population of stroke patients and healthy age-matched controls
at two different time points.
3. The relationship of the aforementioned electrophysiological parameters with
sensorimotor function test scores (ARAT/FM), white matter integrity (based on
MRI), functional network organization (based on fMRI).
Background summary
Many acute stroke patients do not recover completely from motor impairment of
the upper extremities. Previous studies show that motor impairment is
associated with disrupted activity in the motor network of the brain.
Non-invasive brain stimulation techniques, such as transcranial magnetic
stimulation (TMS), can be used to restore disrupted brain activity and to
facilitate the recovery of motor function in patients with stroke. Previous
research shows that continuous theta burst stimulation (cTBS), an inhibitory
form of TMS, has a positive effect on the recovery of motor function in
patients with stroke. However, a substantial variability exists in the reponse
to this type of treatment. Additionally, little is known about the working
principle of cTBS treatment. The current hypothesis is that contralesional cTBS
treatment directly or indirectly modulates interhemispheric inhibition and
intracortical inhibition. We also hypothesize that the interhemispheric
imbalance in inhibition is different in the subacute phase after a stroke
compared to the chronic phase.
Study objective
The objective of this study is to determine whether contralesional cTBS
treatment modulates the interhemispheric imbalance in excitability or local or
transcallosal inhibitory processes in the motor network of a population of
stroke patients compared to healthy age-matched controls. 10 healthy controls
as part of a pilot study.
Study design
This is an observational cohort study in which we will determine the direct
electrophysiological effect of contralesional cTBS in patients with a stroke
compared to healthy age-matched controls. We will do this at two different
timepoints after stroke onset: in the subacute phase and the chronic phase. At
both timepoints we will perform the same measurements. Firstly, we will assess
a number of electrophysiological measurements and other tests in order to
quantify the level of motor impairment. Next, the patient will undergo 40
second cTBS treatment after which the direct electrophysiological effect will
be assessed by repeating the electrophysiological measurements. Patients and
healthy participants also have the oppertunity to undergo an MRI scan.
Study burden and risks
The risk of participation in this study is negligible. Sensorimotor function
testing, single pulse TMS and MRI have been performed safely in many patients
over the last decades. The side effects of TMS consist of mild and transient
headache or dizziness (risk: 1.1%). The risk of an epileptic seizure is very
rare (risk: 0.02%). Some patients may experience claustrophobia during MRI
acquisition.
We are aware of the burden on patients when they undergo these diagnostic
procedures in an early stage of recovery. However, these data can provide
valuable insight on post-stroke motor recovery and the role neuromodulation
treatment in stroke patients, which can potentially be used to individualize
and improve future rehabilitation treatment.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1. Adult patient age >= 18;
2. First-ever ischemic stroke in one hemisphere;
3. Unilateral paresis of an upper extremity with at least a palpable voluntarily muscle contraction of the deltoid muscle and a maximum Motricity Index (MI) of the hand of 25 (i.e. less force in the affected hand during performance of an opposing thumb movement task compared to the unaffected hand);
4. Inclusion possible between 3 weeks and 3 months after stroke onset;
5. Signed informed consent.
Exclusion criteria
1. Other disabling medical conditions (severe heart disease, severe head trauma, severe mental illness);
2. Severe deficits in communication, memory or understanding which could impede participation, as determined by the treating physician;
3. Contraindications for TMS and MRI (ferrous objects in or around the body, history of epilepsy, drug or alcohol abuse over a period of 6 months prior to the experiment, pregnancy).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67438.041.18 |