Theta Burst Stimulation for Motor Recovery

Study Overview
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Brief Summary
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Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS 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. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Official Title
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Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients

Conditions
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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: 1.Unilateral ischemic or hemorrhagic stroke 2.Stroke within 3 months 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases. 5.Patient could sit over 15 minutes 6.Age over 20 Exclusion Criteria: 1.Previous stroke, traumatic brain injury, brain tumor 2.With central nervous system disease (spinal cord injury, Parkinson's disease) 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker) 4.Patients unable to cooperate the treatment 5.Pregnancy 6.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: contralateral 1Hz+ipsilateral iTBS 1<br>Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1 | 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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.<br>|
| Experimental: contralateral 1Hz+ipsilateral iTBS 2<br>Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2 | 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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.<br>|
| Active Comparator: contralateral 1Hz<br>Patients received contralateral 1 Hz and ipsilateral sham iTBS | 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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect.<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 and 24 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 and 24 weeks post intervention | 
| Barthel Index | Barthel Index, score 100-0. Higher scores indicate a better outcome. | 1 week, 4 weeks, 12 weeks and 24 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 and 24 weeks post intervention | 
| MEP | motor evoked potential | 1 week, 4 weeks, 12 weeks and 24 weeks post intervention | 
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 1 week post intervention | 
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 4 weeks post intervention | 
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 24 weeks post intervention |