rTMS Study to Improve Functional Performance for Patients With Stroke

Study Overview
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Brief Summary
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To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.

Detailed Description
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Protocol: Setting: inpatient rehabilitation department of Shuang-Ho Hospital. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. Study design: controlled trial with stratified randomization Blinding The patients were blinded by the real or sham coil of rTMS The assessors who performed the outcome measurements were blinded to the assignment of treatment. Measurements. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. Clinical assessments. Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) Timed Up and Go (TUG) test was used to assess the gross mobility. Barthel Index (BI) for the ADL independence modified Rankin Scale (MRS) for disability classification were also collected. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.

Official Title
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The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.

Conditions
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Stroke

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral hemiplegia caused by the stroke, first ever stroke, time since stroke: 10-90 days, age: 18-80 y/o, Functional ambulation classification (FAC): 0-2, Exclusion Criteria: contraindication to TMS (eg, pacemaker, seizure history, pregnancy), cranial metal implants intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy able to complete Timed Up and Go (TUG) test within 2 minutes unable to walk normally before the stroke those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real rTMS<br>Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins. | Device: rTMS<br>* Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.<br>* Other names: Magstim Rapid2;|
| Sham Comparator: sham rTMS<br>the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes. | Device: rTMS<br>* Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.<br>* Other names: Magstim Rapid2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) |  | Up to 3 months after interventions completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) |  | up to 3 months after the intervention completed | 
| The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) |  | up to 3 months after the interventions completed | 
| Barthel Index (BI) |  | Up to 3 months after interventions completed | 
| Postural control was assessed by Postural Assessment Scale for Stroke (PASS) | PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke. | up to 3 months after the intervention completed | 
| modified Rankin Scale (MRS) |  | Up to 3 months after interventions completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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repetitive transcranial magnetic stimulation, postural, balance, mobility, leg, stroke