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Recruiting NCT06681207

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: anodal transcranial direct current stimulation (a-tDCS).
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Combination product 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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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\*

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Physical Therapy, University of Texas Medical Branch — Galveston

Identifiers

NCT: NCT06681207 · 24-0234

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗