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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442868
• Other study ID #: 19219
• Status: Completed
• Phase: N/A
• Start date: October 19, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2020
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Woman's University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in Counting Task Performance	number of correct responses in counting backward task	before and 10 minutes after the non-invasive brain stimulation