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

Официальное название

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

Обзор

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

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning [Срок оценки: 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 [Срок оценки: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training]

Вторичные конечные точки (2)

• Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning [Срок оценки: 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 [Срок оценки: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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\*

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Physical Therapy, University of Texas Medical Branch — Galveston

Идентификаторы

NCT: NCT06681207 · 24-0234

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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