Individualized rTMS for Motor Recovery in Stroke Patients

Study Overview
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Brief Summary
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This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Detailed Description
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Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. However, the current rTMS studies for stroke patients utilized the same therapeutic protocol and there is no individualized rTMS protocol based on the value of lateralization index. This study aimed to aim to investigate the efficacy of individualized rTMS according to lateralization index on motor recovery and cortical excitability in subacute stroke patients.

Official Title
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Efficacy of Individualized Repetitive Transcranial Magnetic Stimulation Based on Cortical Laterality for Motor Recovery in Stroke Patients

Conditions
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Stroke, Transcranial Magnetic Stimulation

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral ischemic or hemorrhagic stroke Stroke within 3 months Medical Research Council Scale for Muscle Strength in upper limb ≤ 3 No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases. Patient could sit over 15 minutes Age over 20 Exclusion Criteria: Previous stroke, traumatic brain injury, brain tumor With central nervous system disease (spinal cord injury, Parkinson's disease) Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker) Patients unable to cooperate the treatment Pregnancy Depression

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: individualized rTMS<br>Patients will receive individualized repetitive transcranial magnetic stimulation according to lateralization index measured by functional near-infrared spectroscopy | Device: Repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.<br>|
| Active Comparator: Traditional rTMS<br>Control group is given traditional rTMS | Device: Repetitive transcranial magnetic stimulation<br>* Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 12 weeks post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Research Council (MRC) Scale for Muscle Strength | Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction). | 1 week, 4 weeks, 12 weeks post intervention | 
| National Institutes of Health Stroke Scale | National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome. | 1 week, 4 weeks, 12 weeks post intervention | 
| Barthel Index | Barthel Index, score 100-0. Higher scores indicate a better outcome. | 1 week, 4 weeks, 12 weeks post intervention | 
| Modified Rankin Scale | Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome. | 1 week, 4 weeks, 12 weeks post intervention | 
| MEP | motor evoked potential | 1 week, 4 weeks, 12 weeks post intervention | 
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 1 week, 4 weeks post intervention | 
| functional NIRS | Functional Near Infrared Spectroscopy to detect the cortical excitability | 1 week, 4 weeks, 12 weeks post intervention |