rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke

Study Overview
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Brief Summary
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The study will enroll 5 individuals post-stroke to examine the feasibility and efficacy of a high frequency repetitive transcranial magnetic stimulation (rTMS) combined with body weight supported treadmill training.

Detailed Description
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The purpose of this pilot study is to examine the feasibility and efficacy of 5Hz repetitive transcranial magnetic stimulation (rTMS) applied to bilateral motor areas as an adjuvant intervention to task-specific body weight supported treadmill training (BWSTT) in individuals with subacute stroke. Five individuals with a diagnosis of subacute stroke will be recruited and assigned to either high frequency or sham rTMS group.Both groups will receive a comprehensive assessment of their motor function, gait performance and neurophysiological function before the training. Both groups will then go through a 10 week (24 sessions) of gait training with body weight supported treadmill. For the high frequency rTMS group, they will receive 5 Hz rTMS applied to bilateral motor areas prior to each gait training session. For the sham rTMS group, they will receive a sham stimulation prior to the gait training sessions. All participants will receive another comprehensive assessment after the training concludes. The assessor will be blinded to the intervention.

Official Title
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High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Body Weight Supported Treadmill Training (BWSTT) After Stroke: A Pilot Study

Conditions
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Stroke

Intervention / Treatment
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* Device: High Frequency rTMS
* Device: Sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old < 2 months post stroke at the time of enrollment first time stroke: able to walk > 25 feet with or without assistive device and with no more than moderate assistance: able to follow 1-step commands able to communicate verbally Exclusion Criteria: severe medical problems (e.g. recent cardiac infarct, heart failure, cancer) presence of conditions that could affect gait training (e.g. amputation, severe arthritis) bilateral stroke non-ambulatory prior to stroke BMI > 40 any contraindications to TMS (e.g. history of seizure, cardiac pacemaker, metal or magnetic implants) pregnant or potentially to be pregnant

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Frequency rTMS<br>The High Frequency rTMS group will receive real repetitive transcranial magnetic stimulation (rTMS) in 5Hz at 90% of resting motor threshold delivered to the bilateral motor areas via a figure of 8 air-filmed coil. The stimulation is structured as 24 10-second trains with a inter-train interval of 30 second. | Device: High Frequency rTMS<br>* Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.<br>|
| Sham Comparator: Sham rTMS<br>The Sham rTMS group will receive the same protocol but delivered via a sham coil which generates the same auditory and cutaneous feedback as the real stimulation. However, there will be no active stimulation. | Device: Sham rTMS<br>* Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking Speed | Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | Quality of life will be measure using Stroke Impact Scale (SIS). The SIS is a paper and pencil questionnaire consisting 59 items grouped into 8 domains. Each item is rated on a 5-point Likert scale; a higher item score indicates a lower level of difficulty experienced with the item. Item scores are averaged and transformed into domain scores ranging from 0 to 100. A higher domain score indicates a lower level of difficulty. The SIS is well-validated in stroke. | 10 weeks | 
| Change in Motor Function | Motor function will be quantified using Fugl-Meyer Motor Assessment. The Fugl-Meyer Assessment is well-validated in stroke and has a total score ranging from 0 to 100. A higher total score suggests a better level of motor function. | 10 weeks | 
| Change in Cortical Excitability | Cortical excitability will be measured using single pulse transcranial magnetic stimulation. Excitability will be quantified using motor evoked potential amplitude (in mV). A higher motor evoked potential amplitude indicates a greater level of excitability. | 10 weeks | 
| Change in Walking Endurance | Walking endurance will be measured using Six Minute Walk Test and measured in meters. A higher score in the 6 minute walk test (in meters) indicates a better walking endurance. | 10 weeks |