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

Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A Repetitive Transcranial Magnetic Stimulation (rTMS) Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: high frequency rTMS

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Texas Woman's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High frequency rTMS; High frequency rTMS will be applied to different neural loci based on the randomized sessions.	Device: high frequency rTMS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Speed	gait speed in m/s will be captured using GaitRite gait assessment walkway	before and 10 minutes after the non-invasive brain stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Step Lengths	Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway	before and 10 minutes after the non-invasive brain stimulation
Change in Single Support Times	Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway	before and 10 minutes after the non-invasive brain stimulation
Change in Counting Task Performance	number of correct responses in counting backward task	before and 10 minutes after the non-invasive brain stimulation

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Investigators: Principal Investigator: Hui-Ting Goh, Texas Woman's University

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 19219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes