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Идёт набор NCT06743607

Spinal Stimulation for Upper Extremity Recovery in the Home

Без фазы С лечением Cervical Spinal Cord Injury

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: Immediate Intervention, Waitlist control.
Кому может быть актуально
Состояния в реестре: Cervical Spinal Cord Injury. Базовые параметры: от 18 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

Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])

Обзор

The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and/or community in combination with a functional home exercise program for the upper extremities (arm/hand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \[at weeks 0, 8, and 12\] if in group two), 24 1-hour training sessions (2x/week in home with caregiver/companion support and 1x/week with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).

Вмешательства

  • Поведенческое Immediate Intervention
    Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences immediately after enrollment.
  • Поведенческое Waitlist control
    Participants will engage in a home exercise therapy program in combination with transcutaneous spinal stimulation intended to focus on the upper extremities that commences 12 weeks after enrollment.

Первичные конечные точки

  • Capabilities of Upper Extremity Questionnaire (CUE-Q) [Срок оценки: Weeks 0, 8, 12, 21, and 25]
Вторичные конечные точки (9)
  • Graded Refined Assessment of Strength, Sensibility, and Prehension (GRASSP) [Срок оценки: Weeks 0, 8, 12, 21, and 25]
  • International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [Срок оценки: Weeks 0, 8, 12, 21, and 25]
  • Pinch and Grasp Force [Срок оценки: Weeks 0, 8, 12, 21, and 25]
  • Global Rating of Change (GRC) [Срок оценки: Weeks 8, 12, 21, and 25]
  • Satisfaction with Treatment Scale [Срок оценки: Weeks 8, 12, 21, and 25]
  • Qualitative Questions [Срок оценки: Weeks 8 and 21]
  • Canadian Occupational Performance Measure (COPM) [Срок оценки: Weeks 0, 8, 12, 21, and 25]
  • International Spinal Cord Injury Quality of Life Basic Data Set (QoL-BDS) Version 2.0 [Срок оценки: Weeks 0, 8, 12, 21, and 25]
  • International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) Version 3.0 [Срок оценки: Weeks 0, 8, 12, 21, and 25]

Критерии участия

Критерии включения

  • Age 18 or older
  • History of traumatic SCI
  • Less than 12 months post SCI
  • SCI injury level C1-C8
  • SCI categorized as AIS B-D
  • Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows
  • Have caregiver support to attend three in-person sessions and ongoing training at home
  • Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS
  • Able to complete in-person training sessions and return to Craig Hospital for assessments
  • Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation
  • If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures
  • Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device
  • Able to provide informed consent

Критерии исключения

  • Experience unstable chronic cardiac or respiratory complaints
  • Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention
  • Received Botox injections to the UEs, neck, or hands within the last three months
  • Pregnant, planning to become pregnant, or currently breastfeeding
  • Have breakdown in skin area that will come into contact with electrodes
  • Prior nerve or tendon transfer procedure for the UEs
  • Concurrently are participating in another drug or device trial that may interfere with this study
  • Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump
  • In the opinion of the investigators, the study is not safe or appropriate for the participant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Craig Hospital — Englewood

Идентификаторы

NCT: NCT06743607 · 2274573-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗