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Completed

NCT Number: NCT03442868

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's University

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High frequency rTMS

Device

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 outcomes

  1. Change in Gait Speed

    Time frame: before and 10 minutes after the non-invasive brain stimulation

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

Secondary outcomes

  1. Change in Step Lengths

    Time frame: before and 10 minutes after the non-invasive brain stimulation

    Step lengths in centimeter (cm) will be captured using GaitRite gait assessment walkway

  2. Change in Single Support Times

    Time frame: before and 10 minutes after the non-invasive brain stimulation

    Single support times (in % of gait cycle) will be captured using GaitRite gait assessment walkway

  3. Change in Counting Task Performance

    Time frame: before and 10 minutes after the non-invasive brain stimulation

    number of correct responses in counting backward task

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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