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NCT Number: NCT06681207

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

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

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Key information

Conditions

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

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy, University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location status: Recruiting

Location contact

Shih-Chiao Tseng, PT, PhD

CONTACT

[email protected]

409-772-9555

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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*

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

  2. 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

    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

Secondary outcomes

  1. Mean change from baseline in lower extremity (LE) motor function 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

    LE motor function will be quantified by Fugl-Meyer LE motor test, Short Physical Performance Battery (SPPB), and gait speed (meters/second) during ground walking tests.

  2. Mean change from baseline in brain neuronal network 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

    The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes

Study contacts

Contact information is provided by the study sponsor or research team.

Shih-Chiao Tseng, PT, PhD

CONTACT

[email protected]

409--772-9555

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • American Heart Association

Registry information

Official study title

An Exploratory Study: The Effects of Cortical Priming on Visuomotor Stepping Learning in Healthy Adults and Persons With Chronic Stroke

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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