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

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

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Device: High Frequency rTMS; Device: Sham rTMS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-80 years old
2. < 2 months post stroke at the time of enrollment
3. first time stroke:
4. able to walk > 25 feet with or without assistive device and with no more than moderate assistance:
5. able to follow 1-step commands
6. able to communicate verbally

Exclusion Criteria:

1. severe medical problems (e.g. recent cardiac infarct, heart failure, cancer)
2. presence of conditions that could affect gait training (e.g. amputation, severe arthritis)
3. bilateral stroke
4. non-ambulatory prior to stroke
5. BMI > 40
6. any contraindications to TMS (e.g. history of seizure, cardiac pacemaker, metal or magnetic implants)
7. pregnant or potentially to be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Frequency rTMS; 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; 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.
Sham Comparator: Sham rTMS; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Principal Investigator: Hui-Ting Goh, Texas Woman's University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Body Weight
• Other Study ID Numbers: 19883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes