Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
454 participants
INTERVENTIONAL
2024-12-09
2029-12-31
Brief Summary
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Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center.
Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial.
Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset.
Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb.
Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active cTBS
Active cTBS delivered with an active TMS coil
Active cTBS
10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Sham cTBS
Sham cTBS delivered with a sham TMS coil
Sham cTBS
10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Interventions
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Active cTBS
10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Sham cTBS
10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
* Other contra-indications that may potentially be harmful as determined by the treating rehabilitation physician;
* 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.
18 Years
ALL
No
Sponsors
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Jord Vink
OTHER
Responsible Party
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Jord Vink
dr.
Locations
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Tolbrug
's-Hertogenbosch, , Netherlands
Reade
Amsterdam, , Netherlands
Revalidatie Friesland
Beetsterzwaag, , Netherlands
Revant
Breda, , Netherlands
MRC Aardenburg
Doorn, , Netherlands
Libra Blixembosch
Eindhoven, , Netherlands
University Medical Center Groningen
Groesbeek, , Netherlands
Merem
Hilversum, , Netherlands
Adelante
Hoensbroek, , Netherlands
Basalt
Leiden, , Netherlands
Sint Maartenskliniek
Nijmegen, , Netherlands
Basalt
The Hague, , Netherlands
Libra Leijpark
Tilburg, , Netherlands
De Hoogstraat
Utrecht, , Netherlands
Heliomare
Wijk aan Zee, , Netherlands
Vogellanden
Zwolle, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Cynthia Klinkers
Role: primary
Marissa Riemens
Role: primary
Lisa Kruisheer
Role: primary
Daphne Stranders
Role: primary
Henk Meulenbelt
Role: primary
Maijke van Bloemendaal
Role: primary
Karin Peek
Role: backup
Annelies Mantje
Role: primary
Nelleke Kooiman
Role: primary
Iris Habets
Role: primary
Mirjam Kouwenhoven
Role: primary
Deborah Wit
Role: primary
Bente Visser
Role: primary
Other Identifiers
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85511
Identifier Type: OTHER
Identifier Source: secondary_id
NL85511.041.24
Identifier Type: -
Identifier Source: org_study_id
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