Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease

Study Overview
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Brief Summary
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To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.

Detailed Description
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It is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere. repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. Low frequency rTMS (LFrTMS) on contralesional hemisphere or high frequency rTMS (HFrTMS) on lesional hemisphere might be the basic choice. 6 hertz(Hz) primed LFrTMS on lesional primary motor cortex has the stronger effect than LFrTMS alone does on one hand; the other newly-developed combination, i.e. HFrTMS on lesional primary motor cortex and LFrTMS on contralesional primary motor cortex might also be more effective than they do respectively on the other hand. The main aim of our research is to find out which combination is better by considering both safety and efficiency.

Official Title
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Series Study About the rTMS Effects on the Recovery of Limb Motor Dysfunction Due to Cerebral Vascular Disease, Part 1: Comparing the Effects of Various Combinations Between 6 Hertz(Hz) rTMS & LFrTMS.

Conditions
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Cerebrovascular Disease

Intervention / Treatment
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* Device: real LFrTMS at unaffected M1
* Device: real primed LFrTMS at unaffected M1
* Device: combined rTMS at both M1
* Device: all sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 30 to 90 years; Newly onset cerebral infarction or brain hemorrhage confirmed by MRI or CT; the disease duration is less than 20 weeks when recruited into the trial; no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset; the physical and mental condition are good enough to cooperate with the assessment and treatment; the NIHSS score: total 5-20,1a,1b,1c=0; the subject or legal guardian sign the consent form. Exclusion Criteria: during pregnancy; with skull defect; with metal implants, cardiac pacemaker, cochlear implantation; epileptiform discharge in EEG.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 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: combined rTMS at both M1<br>combined rTMS at both M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / real 6 Hz rTMS on affected M1 | Device: combined rTMS at both M1<br>* Compare the effect of combined rTMS at both M1 to that of primed LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③.<br>|
| Experimental: real primed LFrTMS at unaffected M1<br>real primed LFrTMS at unaffected M1: real 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1 | Device: real primed LFrTMS at unaffected M1<br>* Compare the effect of primed LFrTMS at unaffected M1 to that of LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③.<br>|
| Active Comparator: real LFrTMS at unaffected M1<br>real LFrTMS at unaffected M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1 | Device: real LFrTMS at unaffected M1<br>* Compare the effect of LFrTMS at unaffected M1 to that of all sham stimulation on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③.<br>|
| Sham Comparator: all sham stimulation<br>all sham stimulation： sham 6 hertz(Hz) rTMS on unaffected M1 / sham 1 Hz rTMS on unaffected M1 /sham 6 Hz rTMS on affected M1 | Device: all sham stimulation<br>* used as controls to eliminate the placebo effect of all kinds of combinated rTMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer assessment (FMA) | Score of Fugl-Meyer assessment | 1) Before treatment (Baseline); 2) Change from Baseline FMA at the 1st workday after the last treatment; 3) Change from Baseline FMA at the 28th natural day after the last treatment | 
| Simple Test for Evaluating Hand Function (STEF) | Score of Simple Test for Evaluating Hand Function | 1) Before treatment (Baseline); 2) Change from Baseline STEF at the 1st workday after the last treatment; 3) Change from Baseline STEF at the 28th natural day after the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institute of Health Stroke Scale (NIHSS) | Score of National Institute of Health Stroke Scale | 1) Before treatment (Baseline); 2) Change from Baseline NIHSS at the 1st workday after the last treatment; 3) Change from Baseline NIHSS at the 28th natural day after the last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebrovascular Disease, Repetitive Transcranial Magnetic Stimulation