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

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ClinicalTrials.gov Identifier: NCT03441334
Recruitment Status : Terminated (The enrollment was not achieved within proposed timeframe.)
First Posted : February 22, 2018
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Hui Ting Goh, Texas Woman's University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: High Frequency rTMS Device: Sham rTMS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Body Weight Supported Treadmill Training (BWSTT) After Stroke: A Pilot Study
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. change in walking speed [ Time Frame: 10 weeks ]
    Participant's regular and fast walking speeds (in m/s) will be measured using GaitRite. A faster walking speed indicates a better gait performance.


Secondary Outcome Measures :
  1. change in quality of life [ Time Frame: 10 weeks ]
    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.

  2. change in motor function [ Time Frame: 10 weeks ]
    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.

  3. change in cortical excitability [ Time Frame: 10 weeks ]
    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.

  4. change in walking endurance [ Time Frame: 10 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441334


Locations
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United States, Texas
Texas Woman's University
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Texas Woman's University
Investigators
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Principal Investigator: Hui-Ting Goh Texas Woman's University
More Information
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Responsible Party: Hui Ting Goh, Assistant Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03441334    
Other Study ID Numbers: 19883
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Stroke
Body Weight
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases