Clinical trial NCT03441334: rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke
Official title: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Body Weight Supported Treadmill Training (BWSTT) After Stroke: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Walking Speed
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: 10 weeks
measure: Change in Motor Function
timeFrame: 10 weeks
measure: Change in Cortical Excitability
timeFrame: 10 weeks
measure: Change in Walking Endurance
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Hui-Ting Goh
role: PRINCIPAL_INVESTIGATOR
References: