Explore the Effects of Cortical Priming on Visuomotor Stepping Learning in Persons With Chronic Stroke

NCT ID: NCT06681207

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2026-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type: COMBINATION_PRODUCT

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.

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.

Group Type: EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type: COMBINATION_PRODUCT

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.

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.

Group Type: EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type: COMBINATION_PRODUCT

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.

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.

Group Type: EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type: COMBINATION_PRODUCT

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.

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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*

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih-Chiao Tseng, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Physical Therapy, University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shih-Chiao Tseng, PT, PhD

Role: CONTACT

shtseng@utmb.edu

409--772-9555

Facility Contacts

Shih-Chiao Tseng, PT, PhD

Role: primary

shtseng@utmb.edu

409-772-9555

Other Identifiers

24-0234

Identifier Type: -

Identifier Source: org_study_id