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

NCT04437251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-06-18

No results posted yet for this study

Summary

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.

Conditions

  • Vascular Accident, Brain
  • CVA (Cerebrovascular Accident)
  • Gait, Hemiplegic
  • Spastic Lower Extremity Weakness

Interventions

DEVICE

Transcranial direct current stimulation (tDCS)

Transcranial direct current stimulation (tDCS) is an non-invasive, low-intensity direct current stimulation. The stimulation intensity is very low (0- 2 mA) to only produce tingling sensation on the scalp. From literature, there were no serious adverse effects reported after 20-minute stimulation. The main temporary side effect is skill irritation, itching sensation at the stimulation site during or after stimulation.

Sponsors & Collaborators

  • Texas Woman's University

    lead OTHER

Principal Investigators

  • Shih-Chiao Tseng, PT, PhD · Texas Woman's University School of Physical Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-26
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437251 on ClinicalTrials.gov