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

NCT ID: NCT03441334

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2018-11-26

Brief 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.

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

High Frequency rTMS

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Hui Ting Goh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui-Ting Goh

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

Texas Woman's University

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19883

Identifier Type: -

Identifier Source: org_study_id