The aim of this study is to determine whether cTBS treatment of the contralesional primary motor cortex leads to a reduction in contralesional inhibition from the contralesional to the ipsilesional motor cortex during movement onset.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Premovement interhemispheric inhibition from the contralesional to the
ipsilesional primary motor cortex.
Secondary outcome
Interhemispheric inhibition from the contralesional to the ipsilesional primary
motor cortex at rest
TMS interference of the contralesional primairy motor cortex
Intracortical inhibition of the contralesional primairy motor cortex (optional)
Background summary
Many stroke patients suffer from upper limb impairment and do not recover
completely. Previous studies show that motor impairment is associated with
disrupted activity in the motor areas of the brain. Non-invasive brain
stimulation techniques, such as transcranial magnetic stimulation (TMS), can be
used to influence brain activity and facilitate the recovery of motor function
in patients with stroke. Research from the UMC Utrecht (B-STARS study) showed
that continuous theta burst stimulation (cTBS), an inhibitory form of rTMS,
promotes recovery of the upper limb. However, the response to treatment varies
substantially between patients and little is known about the working principle
of cTBS treatment. Improved understanding of the working mechanism can be used
to select patients who benefit from cTBS treatment.
Study objective
The aim of this study is to determine whether cTBS treatment of the
contralesional primary motor cortex leads to a reduction in contralesional
inhibition from the contralesional to the ipsilesional motor cortex during
movement onset.
Study design
A prospective open-label intervention study
Intervention
cTBS treatment of the contralesional primary motor cortex
Study burden and risks
The risk of participation in this study is negligible. The side effects of TMS
consist of headache (<4%) and neck pain (<1%) and the risk of an epileptic
seizure is very rare (0.02%). Some patients may experience claustrophobia,
dizziness, headache, nausea or sensory sensations during MRI. 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
In order to be eligible to participate in this study, a patient must meet all
of the following criteria:
- Age, 18 years or older;
- First-ever unilateral ischemic stroke or intracerebral hemorrhage in a
cerebral hemisphere or the brainstem;
- Unilateral upper limb paresis with a motricity index between 9 and 99;
- Inclusion possible between 3 weeks and 6 weeks after stroke onset;
- Signed informed consent.
In order to be eligible to participate in this study, a healthy control must
meet all of the following criteria:
- Age >= 18 years;
- Normal motor function with a minimum Motricity Index (MI) of 99;
- Signed informed consent.
Exclusion criteria
- Upper limb paresis prior to stroke onset;
- Absolute contra-indication to TMS: Magnetic sensitive objects implanted in
the head or neck area (e.g. cochlear implants, implanted neurostimulator,
pacemaker or defibrillator, metal splinters, metal fragments or metal clips),
history of epilepsy, pregnancy or other contra-indications that may potentially
be harmful as determined by the treating rehabilitation physician;
- Incompetence or severe impairments that can impede study participation as
determined by the treating rehabilitation physician (i.e. extreme fatigue,
severe communication deficits);
- Life expectancy shorter than one year.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86587.041.24 |