Stroke
Conditions
Keywords
Stroke, Transcranial magnetic stimulation, Continuous theta burst stimulation, Upper limb recovery, TMS, cTBS
Brief summary
Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days. 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
Interventions
DEVICEActive cTBS
10 sessions of active cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
DEVICESham cTBS
10 sessions of sham cTBS delivered to the contralesional primary motor cortex, started within 3 weeks after stroke.
Sponsors
Jord Vink
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Sham cTBS treatment is delivered with a sham TMS-coil.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity section of the Fugl-Meyer Assessment | at 90 days post-stroke | The score ranges from 0 to 66 points with a higher score indicating better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test | at 90 days and 12 months post-stroke | The score ranges from 0 to 57 points with a higher score indicating better outcome |
| modified Rankin Scale | at 90 days and 12 months post-stroke | The score ranges from 0 to 6 points with a lower score indicating better outcome |
| Hand section of Stroke Impact Scale | at 90 days and 12 months post-stroke | The score ranges from 0 to 25 points with a higher score indicating better outcome |
| Participation section of Stroke Impact Scale | at 90 days and 12 months post-stroke | The score ranges from 0 to 40 points with a higher score indicating better outcome |
| Upper extremity section of the Fugl-Meyer Assessment | at 12 months post-stroke | The score ranges from 0 to 66 points with a higher score indicating better outcome |
| Nine Hole Peg Test | at 90 days and 12 months post-stroke | The outcome ranges from 0 to 50 seconds with a shorter outcome indicating better outcome |
| Ipsilesional corticospinal excitability | within 12 hours after the 10th cTBS session | Ipsilesional corticospinal excitability is defined as the resting motor threshold of the ipsilesional hemisphere as determined with single pulse TMS. The outcome ranges from 0 to 100% of the machine output |
| iMTA medical consumption questionnaire | at 6 and 12 months post-stroke | This questionnaire aims to identify costs associated with medical consumption |
| iMTA productivity cost questionnaire | At 6 and 12 months post-stroke | This questionnaire aims to identify costs associated with productivity loss of paid work. |
| EuroQol-5D | at 90 days and 12 months post-stroke | The score ranges from 0 to 5 points per item with a higher score indicating better outcome |
Countries
Netherlands
Contacts
Primary ContactJord Vink, PhD
Outcome results
None listed