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Набор скоро начнётся NCT06140706

Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

Без фазы С лечением Tetraplegia

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: transcutaneous Spinal Cord Stimulation (tSCS).
Кому может быть актуально
Состояния в реестре: Tetraplegia. Базовые параметры: 18 лет — 75 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

Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function

Обзор

The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.

Подробное описание

The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.

The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.

Вмешательства

  • Поведенческое transcutaneous Spinal Cord Stimulation (tSCS)
    Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.

Первичные конечные точки

  • NASA-TLX (NASA Task Load Index) [Срок оценки: At 8 weeks (after completion of home program)]
  • QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology) [Срок оценки: At 8 weeks (after completion of home program)]
Вторичные конечные точки (4)
  • GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension) [Срок оценки: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
  • CUE-Q (Capabilities of Upper Extremity Function) [Срок оценки: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
  • DASH (Disabilities of the Arm, Shoulder, and Hand) [Срок оценки: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]
  • COPM (Canadian Occupational Performance Measure) [Срок оценки: At entry (Baseline) and repeated at 8 weeks (after completion of home program)]

Критерии участия

Критерии включения

  • Veteran
  • Age 18-65
  • All gender, any ethnicity
  • Cervical Spinal Cord Injury C2-8
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
  • GRASSP-Prehension Score >10 or GRASSP Strength Score >30
  • Greater than 1 year post injury
  • Able to identify a companion to assist with neurostimulator setup in home environment.
  • Internet connection to support video telehealth connection
  • Willingness to travel to the VA Palo Alto Medical Center

Критерии исключения

  • Cardiopulmonary disease or cardiac symptoms,
  • Autonomic dysreflexia that is uncontrolled or severe,
  • Implanted medical device(s),
  • Uncontrolled spasms that could limit participation in exercise training,
  • Skin breakdown or active pressure injury in areas of electrode placement.
  • Participants must not be engaged in any concurrent drug or device trial
  • Pregnant, are planning to become pregnant, or breastfeeding
  • The study is not deemed safe or appropriate in the opinion of the investigators

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 · 1 центр
  • VA Palo Alto Health Care System — Palo Alto

Идентификаторы

NCT: NCT06140706 · IRB-68905

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗