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

Texas Woman's University

Status: Terminated

Conditions: Stroke

Treatments: Device: Sham rTMS; Device: High Frequency rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03441334

19883

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

High Frequency rTMS

Experimental group

Description:

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.

Treatment:

Device: High Frequency rTMS

Sham rTMS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham rTMS