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Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high frequency rTMS
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age above 18 years
  2. Diagnosis of Left hemispheric stroke at least 6 months ago
  3. First time stroke OR complete gait recovery from prior stroke
  4. Able to walk independently for at least 10 meters with or without walking aids
  5. Have at least minimal movements (> 5 degree of motion) at the affected ankle
  6. Score > 26 on Mini Mental State Exam (MMSE)
  7. Ability to participate in the informed consent process

Exclusion Criteria:

  1. Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis
  2. Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis)
  3. Unstable clinical conditions
  4. Non-ambulatory prior to onset of stroke
  5. History of significant head trauma
  6. Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip
  7. Metal implantation in the oral cavity, head/neck area and lower extremity
  8. Pregnancy
  9. History of seizures or unexplained loss of consciousness
  10. Immediate family member with epilepsy
  11. Use of seizure threshold lowering medicine
  12. Current abuse of alcohol or drugs
  13. Anticipated inability to complete the study
  14. History of psychiatric illness requiring medication control

Sites / Locations

  • Texas Woman's University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High frequency rTMS

Arm Description

High frequency rTMS will be applied to different neural loci based on the randomized sessions.

Outcomes

Primary Outcome Measures

Change in Gait Speed
gait speed in m/s will be captured using GaitRite gait assessment walkway

Secondary Outcome Measures

Change in Step Lengths
Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway
Change in Single Support Times
Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway
Change in Counting Task Performance
number of correct responses in counting backward task

Full Information

First Posted
February 9, 2018
Last Updated
November 19, 2020
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT03442868
Brief Title
Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke
Official Title
Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 19, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study aims to identify neural locus critical for dual-task walking (walking and talking) in individuals with stroke. To achieve this aim, the investigators apply repetitive transcranial magnetic stimulation (rTMS) to different parts of the brain and evaluate the effects of brain stimulation on dual-task walking speed.
Detailed Description
This study will enroll 12 individuals with a stroke at least 6 months ago. Participants will be tested across 3 sessions and each session will be approximately 1 week apart from each other. During testing, participants will be asked to walk under two conditions: single- and dual-task conditions. Under the single-task condition, participants walk on a instrumented mat such that their gait performance will be captured. Under the dual-task condition, participants walk on the mat while performing a counting backward task. The walking assessment is followed by a 12 minute non-invasive brain stimulation using high frequency rTMS. Another walking assessment will be conducted right after the brain stimulation session. High frequency rTMS will be applied to different neural loci, namely primary motor cortex (M1), supplementary motor area (SMA), and dorsolateral prefrontal cortex (DLPFC). The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High frequency rTMS
Arm Type
Experimental
Arm Description
High frequency rTMS will be applied to different neural loci based on the randomized sessions.
Intervention Type
Device
Intervention Name(s)
high frequency rTMS
Intervention Description
Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex (M1), supplementary motor area (SMA) and dorsolateral prefrontal cortex (DLPFC) at different sessions. Walking performance is evaluated before and after the brain stimulation.
Primary Outcome Measure Information:
Title
Change in Gait Speed
Description
gait speed in m/s will be captured using GaitRite gait assessment walkway
Time Frame
before and 10 minutes after the non-invasive brain stimulation
Secondary Outcome Measure Information:
Title
Change in Step Lengths
Description
Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway
Time Frame
before and 10 minutes after the non-invasive brain stimulation
Title
Change in Single Support Times
Description
Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway
Time Frame
before and 10 minutes after the non-invasive brain stimulation
Title
Change in Counting Task Performance
Description
number of correct responses in counting backward task
Time Frame
before and 10 minutes after the non-invasive brain stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years Diagnosis of Left hemispheric stroke at least 6 months ago First time stroke OR complete gait recovery from prior stroke Able to walk independently for at least 10 meters with or without walking aids Have at least minimal movements (> 5 degree of motion) at the affected ankle Score > 26 on Mini Mental State Exam (MMSE) Ability to participate in the informed consent process Exclusion Criteria: Diagnosis of other neurological conditions, such as Parkinson Disease, Alzheimer, Spinal Cord Injury, Multiple Sclerosis Other comorbidities which could interfere with gait (i.e. amputation, severe osteoarthritis) Unstable clinical conditions Non-ambulatory prior to onset of stroke History of significant head trauma Electrical, magnetic, or mechanical implantation: cardiac pacemakers or intracerebral vascular clip Metal implantation in the oral cavity, head/neck area and lower extremity Pregnancy History of seizures or unexplained loss of consciousness Immediate family member with epilepsy Use of seizure threshold lowering medicine Current abuse of alcohol or drugs Anticipated inability to complete the study History of psychiatric illness requiring medication control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Ting Goh
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Woman's University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Non-invasive Brain Stimulation (NIBS) and Dual-task Walking After Stroke

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