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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03441334
• Other study ID #: 19883
• Status: Terminated
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: November 26, 2018

Study information

• Verified date: May 2023
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 26, 2018
• Est. primary completion date: November 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Stroke

Intervention

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 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.

Locations

Country	Name	City	State
United States	Texas Woman's University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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