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Идёт набор NCT07397559

Spatiotemporal tSCS in Spinal Cord Injury

Без фазы С лечением Spinal Cord Injuries (SCI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No Stimulation, Conventional tSCS, Spatiotemporal tSCS.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries (SCI). Базовые параметры: 16 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI

Обзор

Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.

Подробное описание

Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.

Вмешательства

  • Другое No Stimulation
    Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.
  • Устройство Conventional tSCS
    Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks
  • Устройство Spatiotemporal tSCS
    Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

Первичные конечные точки

  • Changes in Torque [Срок оценки: 30 minutes]
Вторичные конечные точки (2)
  • Muscle activation [Срок оценки: 30 minutes]
  • Pain/Nociception [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

  • Age between 16 and 65 years.
  • Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
  • Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
  • Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
  • Able to provide consent
  • Ability to follow multiple instructions and communicate pain or discomfort

Критерии исключения

  • Progressive spinal lesions, including degenerative disorders of the spinal cord
  • Pregnant, planning to become pregnant, or currently breastfeeding
  • History of cardiopulmonary disease or cardiac symptoms
  • Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
  • Presence of orthopedic conditions that would negatively affect participation in leg exercise
  • History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
  • Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
  • Spasms that limit the ability to participate in leg exercise activity
  • Breakdown in skin area that will be in contact with electrodes

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • Washington University, St. Louis — St Louis

Идентификаторы

NCT: NCT07397559 · 202506064

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗