Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

NIBS and Dual-task Walking After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03442868
Recruitment Status : Completed
First Posted : February 22, 2018
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hui Ting Goh, Texas Woman's University

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.

Condition or disease Intervention/treatment Phase
Stroke Device: high frequency rTMS Not Applicable

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, supplementary cortex, and dorsolateral prefrontal cortex. The walking speed under two different conditions will be compared before and after brain stimulation to different neural loci.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Non-Invasive Brain Stimulation on Dual-Task Walking After Stroke: A rTMS Study
Actual Study Start Date : October 19, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

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, supplementary motor areas and dorsolateral prefrontal cortex at different sessions. Walking performance is evaluated before and after the brain stimulation.




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. change in step lengths [ Time Frame: before and 10 minutes after the non-invasive brain stimulation ]
    Step lengths in m will be captured using GaitRite

  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

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03442868


Locations
Layout table for location information
United States, Texas
Texas Woman's University
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Texas Woman's University
Investigators
Layout table for investigator information
Principal Investigator: Hui-Ting Goh Texas Woman's University

Layout table for additonal information
Responsible Party: Hui Ting Goh, Assistant Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT03442868     History of Changes
Other Study ID Numbers: 19219
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases