Recruiting

Brain Stimulation

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT06681207

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

anodal transcranial direct current stimulation (a-tDCS)

Study Details

Brief summary:

This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.

Conditions

Stroke

Study ID

NCT06681207

Start date

Apr 23, 2025

Status verified date

Sep, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age between 21 and 90 years
2. Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment
3. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract
4. Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test)
5. No passive range of motion limitation in bilateral hips and knees
6. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less
7. Visual acuity can be corrected by glasses or contact lens to 20/20
8. Able to walk independently with/without assistant devices for 10 meters
9. Able to maintain standing position without any assistance > 30 sec (Short Physical Performance Battery)
10. Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24

Exclusion Criteria:

1. Pregnant women
2. 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
3. Have any metal implants, cardiac pacemakers, or history of seizures
4. Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training
5. Any vestibular dysfunction or unstable angina
6. Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia\*

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Explore the effects of brain stimulation on locomotor skill learning in stroke survivors

To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON).

experimental: determine the effects of a-tDCS on the cortical excitation before and after locomotor learning

measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants.

experimental: To explore improvements in learning capacity between healthy adults and stroke participants.

Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.

experimental: To explore the trends of functional improvements after five tDCS session in stroke survivors

Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation.

Interventions

anodal transcranial direct current stimulation (a-tDCS)

Stroke participants will be randomly assigned into one of three groups: anodal transcranial direct current stimulation (a-tDCS), sham tDCS (s-tDCS), or control groups (i.e. no brain stimulation). Stroke participants in the first two groups will receive five sessions of the assigned brain stimulation combined with visuomotor stepping training over five consecutive days. Healthy adults will be randomly assignments into a-tDCS or s-tDCS groups.

Primary outcome measure

  • Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning [ Time Frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training ]
  • Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning [ Time Frame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training ]

Central Contacts and Locations

Central contacts

Shih-Chiao Tseng, PT, PhD

409--772-9555shtseng@utmb.edu

Locations

Physical Therapy, University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Shih-Chiao Tseng, PT, PhD

409-772-9555shtseng@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • adult
  • chronic stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-09-24.