Effect of Brain Stimulation on Stepping Performance in Stroke Survivors and Healthy Adults

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Vascular Accident, Brain, CVA (Cerebrovascular Accident), Gait, Hemiplegic, Spastic Lower Extremity Weakness

In brief

Participants are being asked to participate in a research study conducted by Shih-Chiao Tseng, PT, Ph.D. at Texas Woman's University. This research study is to determine whether low-intensive brain stimulation can enhance learning of a leg movement task. The investigators also want to know if brain stimulation can improve the nerve function and walking performance. Our goal is to understand any relationship between brain stimulation and overall movement control improvement. Participants have been invited to join this research if they have had a stroke before or they are healthy adults aged 21 years or older. Research evidence shows stroke can induce permanent brain damage and therefore may cause a person to have trouble learning a new task. This in turn may significantly impact the recovery of motor function in stroke survivors. In addition, the investigators also want to know how a healthy person learns this new leg task and see if her/his learning pattern differs from a stroke survivor. This study comprises two phases: Phase I study investigates short-term effects of brain stimulation on leg skill learning and only requires two visits to TWU. The total time commitment for Phase I study will be about 6.5 hours, 3.5 hours on the first visit and three hours on the second visit; Phase II study is an expanded version of Phase I study to investigate long-term effects of brain stimulation on leg skill learning and requires to complete 12 visits of exercise training paired with brain stimulation over a four-week period and additional one visit for follow-up test. The total time commitment for Phase II study will be about 20 hours, a total of 18 hours for 12 exercise training sessions and two hours for a follow-up test. The investigators hypothesize that people with chronic stroke will show a slower rate of acquiring this leg skill as compared to healthy adults. The investigators also hypothesize that co-applying brain stimulation with 12 sessions of exercise training will enhance skill learning of this leg task for people with chronic stroke and this 12-session exercise program may exert beneficial influences on the nerve function and leg muscle activation, and consequentially improve motor control for walking.

Key facts

Study ID: NCT04437251
Run by: Texas Woman's University
People needed: 180
Starts: 2014-09-26
Expected to finish: 2024-12-31
Last updated by the study team: 2020-06-18

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Healthy adults have no ongoing neurological, musculoskeletal issues.
Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract.
Individuals with chronic stroke have hemiparesis involving the lower extremity.
Individuals with chronic stroke have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or ess.
Visual acuity can be corrected by glasses or contact lens to 20/20.
Able to walk independently with/without assistant devices for 10 meters.
Able to maintain standing position without any assistance for more than 30 sec.
Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24.

You may not qualify if…

Pregnant women.
MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors.
Have any metal implants, cardiac pacemakers, or history of seizures.
Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training.
Any vestibular dysfunction or unstable angina.
Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia*

Where it is running

Texas Woman's University — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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