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This pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.
The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized medical and intensive rehabilitation treatments. The outcome measures included Action Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of ECR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intermittent theta burst stimulation | Experimental |
| |
| sham stimulation | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent theta burst stimulation | Device | Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of Action Research Arm test | We assess the changes of Action Research Arm test between before the intervention and the 60th day post-stroke. | 60th day post-stroke |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of upper limb function and corticospinal excitability | We assess the changes of Fugl-Meyer test (FMT), active motor threshold and motor evoked potentials (MEPs) of paretic ECR between before the intervention and 60th day post-stroke | 60th day post-stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I-Hui Lee, MD PhD | Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22659021 | Result | Hsu YF, Huang YZ, Lin YY, Tang CW, Liao KK, Lee PL, Tsai YA, Cheng HL, Cheng H, Chern CM, Lee IH. Intermittent theta burst stimulation over ipsilesional primary motor cortex of subacute ischemic stroke patients: a pilot study. Brain Stimul. 2013 Mar;6(2):166-74. doi: 10.1016/j.brs.2012.04.007. Epub 2012 May 12. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |