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Идёт набор NCT06455137

Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement

Без фазы С лечением Spinal Cord Injuries

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: Epidural Stimulator.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries. Базовые параметры: 20 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
Тайвань
Следующий шаг
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Обзор

The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.

Подробное описание

The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.

Вмешательства

  • Устройство Epidural Stimulator
    Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.

Первичные конечные точки

  • Electroencephalography and Electromyography [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Electromyographic analysis [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Single transcranial magnetic stimulation [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Motion Analysis [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Functional Test [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
Вторичные конечные точки (9)
  • American Spinal Injury Association (ASIA-2019) Impairment Scale [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Modified Ashworth scale [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Barthel Index [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • World Health Organization Quality of Life Brief Version [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Spinal Cord Independence Measure [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Box and Block Test [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Action Research Arm Test Scoring Sheet [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Berg Balance Scale [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]
  • Walking Index for Spinal Cord Injury II (WISCI II- March 2005) [Срок оценки: To measure assessing change between pre-implant and every 3 months until 24 months.]

Критерии участия

Критерии включения

  • SCI ASIA: A, B, C,D
  • Between 20 and 70 year of age
  • >1 year post SCI
  • Complete or incomplete spinal cord injury.
  • Expected will undergo spinal cord stimulation surgery.
  • Continued rehabilitation after surgery for spinal cord injury.
  • Able to comply with procedures and follow up.
  • Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities

Критерии исключения

  • Have significant cognitive impairment (MMSE<24).
  • Had a mental illness within one year or been treated in the past.
  • Have Major depressive disorder.
  • Active cancer diagnosis.
  • Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
  • Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
  • Unable to read and/or comprehend the consent form.
  • Have concerns about this trial and do not sign consent.

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
Лечение

Центры проведения

Тайвань · 1 центр
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Идентификаторы

NCT: NCT06455137 · IRB112-067-A

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗