MedPath

Brain STimulation for Arm Recovery after Stroke 2

Phase 3
Conditions
Stroke
10007963
Registration Number
NL-OMON56798
Lead Sponsor
niversitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
454
Inclusion 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;
Possibility to start cTBS treatment within 21 days after stroke onset;
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 or other contra-indications that may potentially be harmful as
determined by the treating rehabilitation physician;
Incapacity or severe impairments (i.e. extreme fatigue, major communication
deficits) that can impede study participation as determined by the treating
rehabilitation physician;
Life expectancy shorter than one year.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days<br /><br>post-stroke.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The FM-UE at 12 months post-stroke.<br /><br>The Action Research Arm Test (ARAT) at 90 days and 12 months post-stroke.<br /><br>Activities of daily living (ADL), memory, handfunction and participation<br /><br>sections of the Stroke Impact Scale (SIS) at 90 days and 12 months post-stroke.<br /><br>Nine Hole Peg Test at 90 days and 12 months post-stroke.<br /><br>modified Rankin Scale at 90 days and 12 months post-stroke.<br /><br>EuroQol-5D at 90 days and 12 months post-stroke.<br /><br>iMTA medical consumption and productivity cost questionnaire<br /><br>Length of stay<br /><br>Ipsilesional excitability directly after the 10th cTBS session<br /><br>Contralesional excitability before the 1st, 6th and 10th cTBS session</p><br>
© Copyright 2025. All Rights Reserved by MedPath