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

NCT06681207 | Recruiting

• 1 other identifier: 24-0234
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

adult; chronic stroke

Outcome Measures

Primary Outcomes (2)

• Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning

  Stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen.

  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

  The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations

  Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training

Secondary Outcomes (2)

• Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning

  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 network activations after five sessions of brain stimulation combined with visuomotor stepping learning

  Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training

Study Arms (4)

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

EXPERIMENTAL

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).

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

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

EXPERIMENTAL

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

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

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

EXPERIMENTAL

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

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

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

EXPERIMENTAL

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

Combination Product: anodal transcranial direct current stimulation (a-tDCS)

Interventions

anodal transcranial direct current stimulation (a-tDCS) 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.

Explore the effects of brain stimulation on locomotor skill learning in stroke survivors; To explore improvements in learning capacity between healthy adults and stroke participants.; To explore the trends of functional improvements after five tDCS session in stroke survivors; determine the effects of a-tDCS on the cortical excitation before and after locomotor learning

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21 and 90 years
• 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
• Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test)
• No passive range of motion limitation in bilateral hips and knees
• Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less
• 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 \> 30 sec (Short Physical Performance Battery)
• 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\*

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• American Heart Association: collaborator

Study Sites (1)

Physical Therapy, University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shih-Chiao Tseng, PT, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Chiao Tseng, PT, PhD

CONTACT

409--772-9555; shtseng@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)