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Идёт набор NCT06494020

Task Practice and Spinal Cord Stimulation

Без фазы С лечением Spinal Cord Injury Cervical Spastic

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: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS).
Кому может быть актуально
Состояния в реестре: Spinal Cord Injury Cervical, Spastic. Базовые параметры: 22 лет — 70 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Task Practice Combined With Transcutaneous Spinal Cord Stimulation to Reduce Muscle Co-contraction and Improve Motor Function in Chronic Spinal Cord Injury

Обзор

The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.

Вмешательства

  • Другое Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
    Hand rehabilitative tasks ( for gross hand movement, grasp and pinch tasks) will be done by participants during which time the participant will receive TcSCS. This will be done three times a week for 60 minutes.

Первичные конечные точки

  • Change in motor performance as measured by The Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) test [Срок оценки: baseline, up to 4 months]
Вторичные конечные точки (1)
  • Change in Spasticity as measured by Modified Ashworth Scale (MAS) [Срок оценки: baseline, up to 4 months]

Критерии участия

Критерии включения

  • 22-70 years of age
  • Non-progressive cervical spinal cord injury
  • Minimum 12 months year post-injury.
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D.
  • Able to take part in upper extremity therapy procedures.
  • GRASSP-Prehension score ≥10.
  • MAS Score ≥3 but <6 in at least one arm.
  • Can commit to the time required for the study.
  • Stable medication profile for at least 4 weeks prior to enrollment.
  • Able to reduce Baclofen dose to 30 mg or less daily.
  • Capable of providing informed consent.

Критерии исключения

  • Has any unstable or significant medical condition that is likely to interfere with study procedures like severe neuropathic pain, depression, mood disorders, or other cognitive disorders.
  • Has uncontrolled cardiopulmonary disease or cardiac symptoms.
  • Requires ventilator support.
  • Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled.
  • Has an autoimmune etiology of spinal cord dysfunction/injury
  • Previously diagnosed as having transverse myelitis
  • History of additional neurologic diseases such as stroke, multiple sclerosis, traumatic brain injury, epilepsy or history of seizures.
  • Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
  • Uncontrolled spasms, which have been unstable over the past three months prior to enrollment and are not expected to change.
  • Received Botulinum toxin injections in their upper extremity, neck, or hand within six months prior to enrollment.
  • Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection at the time of enrollment.
  • Breakdown in skin area that will come into contact with electrodes.
  • Presence of syringomyelia as determined by an MRI.
  • Currently undergoing treatment for cancer or has been in remission for less than 2 years.
  • Received stem cell treatment within the past two years prior to enrollment.
  • Has any active implanted medical device.
  • Concurrent participation in another drug or device trial that may interfere with this study.
  • In the opinion of the investigators, the study is not safe or appropriate for the participant.
  • Persons who are unable to consent, pregnant women, and prisoners.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 2 центра
  • University of Miami - Christine E. Lynn Rehabilitation Center — Miami
  • University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis — Miami

Идентификаторы

NCT: NCT06494020 · 20230228

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗