Clinical trial NCT06681207: Explore the Effects of Cortical Priming on Visuomotor Stepping Learning in Persons With Chronic Stroke
Official title: An Exploratory Study: The Effects of Cortical Priming on Visuomotor Stepping Learning in Healthy Adults and Persons With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: adult
chronic stroke
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-11-08
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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\*

Primary outcomes:
measure: Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning
timeFrame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
measure: Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning
timeFrame: 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:
measure: Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning
timeFrame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
measure: Mean change from baseline in brain neuronal network activations after five sessions of brain stimulation combined with visuomotor stepping learning
timeFrame: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Physical Therapy, University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Shih-Chiao Tseng, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: