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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06681207
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-08
• Status Verified: 2024-12
• Study Start: 2025-04-23
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-08-30
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in stepping motor control 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	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.
Mean change from baseline in brain neuronal 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	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 Outcome Measures

Name	Time	Method
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	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.
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	The neuronal activations will be quantified by oxygen consumption changes locally detected by surface infrared diodes

Trial Locations

Locations (1)

Physical Therapy, University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States