Intermittent Theta Burst Stimulation After Acute Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Theta Burst Stimulation on the Motor Cortex in Acute Stroke: a Randomized Controlled Trial

Conditions
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Ischemic Stroke,

Intervention / Treatment
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* Device: Intermittent theta burst stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (MCA) territory, and mild to moderate hand paresis (NIHSS motor arm score 1-2) are enrolled. Exclusion Criteria: age over 75, severe hand paresis without detectable active motor threshold (aMT) of the extensor carpi radialis (ECR), seizure history (clinical or EEG abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intermittent theta burst stimulation<br> | Device: Intermittent theta burst stimulation<br>* Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.<br>|
| Placebo Comparator: sham stimulation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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theta burst stimulation, stroke, motor, plasticity