Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Study Overview
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Brief Summary
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Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Detailed Description
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Stroke is one of the main causes of death and disability in Taiwan. The M1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. 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. Through regulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. Previous study had been demonstrated that priming rehabilitation program with low frequent rTMS would lead to better motor recovery in the chronic stroke patients. However, the optimal time interval between the rTMS and the rehabilitation program had not been investigated. Thus, this study will utilize low frequent rTMS, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rTMS and the rehabilitation program. This study is designed as a randomized controlled trial. We plan to recruit 45 subacute stroke patients with hemiplegia. The patients are randomly assigned to three groups. In the Group 1, the patients receive contralateral 1 Hz rTMS stimulation and subsequent rehabilitation program. In the Group 2, the patients receive contralateral 1 Hz rTMS, but the rehabilitation will be delayed at least two hours after the rTMS stimulation. The control group receive sham rTMS and subsequent rehabilitation program. The treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. The primary outcome is upper limb Fugl-Meyer Assessment. The secondary outcomes included Medical Research Council (MRC) scale, Barthel Scale, Modified Rankin Scale (MRS), cortical excitability assessment (including bilateral maximum MEP amplitude, MEP latency, and bilateral resting motor threshold). Follow-up time points are before rTMS and at 1st, 4th, 12th weeks after the end of the treatments.

Official Title
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Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: rTMS-PTi
* Other: rTMS-PTd
* Other: rTMSs-PT


Participation Criteria
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Eligibility Criteria
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Inclusion criteria >=20 years old, unilateral stroke diagnosed by CT or MRI Post-stroke 1 week to 6 months Medical Research Council Scale for Muscle Strength in upper limb ≤ 3 No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease stable medical condition and vital signs 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, Pregnancy...) Patients unable to cooperate the treatment

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate rehabilitation group<br>rTMS plus immediate rehabilitation programs | Other: rTMS-PTi<br>* 10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs<br>|
| Experimental: delayed rehabilitation group<br>rTMS plus delayed rehabilitation programs | Other: rTMS-PTd<br>* 10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (>2hr)<br>|
| Sham Comparator: sham rTMS group<br>sham rTMS + rehabilitation programs | Other: rTMSs-PT<br>* 10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) | Fugl-Meyer Assessment (FMA) of upper limb | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Research Council (MRC) scale | Medical Research Council (MRC) scale | 12 weeks | 
| Grip strength | Grip strength (Kg) | 12 weeks | 
| Barthel Index | Barthel Index | 12 weeks | 
| Modified Rankin Scale | Modified Rankin Scale | 12 weeks | 
| maximal motor evoked potential amplitude | maximal motor evoked potential amplitude of lesion site (mV) | 12 weeks | 
| motor evoked potential latency | motor evoked potential latency of lesion site (ms) | 12 weeks | 
| resting motor threshold | bilateral resting motor threshold (mV) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, stroke