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Идёт набор NCT06406855

Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)

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: BCI-TSCS.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries. Базовые параметры: 18 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

Brain-Controlled Spinal Stimulation Therapy for Restoration of Walking After Incomplete Spinal Cord Injury (SCI)

Обзор

The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).

Вмешательства

  • Другое BCI-TSCS
    BCI-TSCS therapy, completed 3-4 times per week, that will include activity-based training, with TSCS activated by BCI system detecting movement attempt.

Первичные конечные точки

  • Number of related neurological deterioration (LEMS) [Срок оценки: up to 12 months]
  • Number of treatment related incidence of adverse events (AEs) [Срок оценки: up to 12 months]
  • Number of subjects that complete the study [Срок оценки: up to 12 months]
  • Walking function using 10 meter walk test (10MWT) [Срок оценки: up to 12 months]
  • Walking function using 6 minute walk test (6MWT) [Срок оценки: up to 12 months]
Вторичные конечные точки (8)
  • Mobility measured by Timed Up and Go (TUG) Test [Срок оценки: up to 12 months.]
  • Balance measured by the Berg Balance Scale (BBS) [Срок оценки: up to 12 months.]
  • Muscular spasticity measured by the Modified Ashworth Scale (MAS) [Срок оценки: up to 12 months.]
  • Muscular spasticity measured by the Pendulum Test [Срок оценки: up to 12 months.]
  • Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II) [Срок оценки: up to 12 months]
  • Independence as measured by Spinal Cord Independence Measure (SCIM III) [Срок оценки: up to 12 months]
  • Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL) [Срок оценки: up to 12 months]
  • Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires [Срок оценки: up to 12 months]

Критерии участия

Критерии включения

  • At least 18 years old and no older than 70 years old at the time of enrollment.
  • Traumatic incomplete spinal cord injury (neurological level at or above T10 spinal cord level; Abbreviated Injury Scale (AIS) C or D impairment grade for group 1, 3 and 4 and AIS B, C or D impairment grade for group 2), who are more than 6 months post-injury.
  • Has detectable motor function in at least 2 muscles per side confirmed by voluntary Electromyography (EMG) or detectable tibialis anterior (TA) muscle motor evoked potentials (MEPs) at the baseline assessment.
  • Able to commit to intensive training and assessment sessions over a maximum total duration of 6 months.
  • Could effectively walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support, with functional spasticity (by participant's self-report), functional range-of-motion of lower limb joints, and acceptable bone mass to enable body-weight support, confirmed by Dual-energy X-ray absorptiometry (DXA) scan.

Критерии исключения

  • Has traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
  • Has severe spasticity that could prevent stepping and walking function determined by the investigator.
  • Has major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
  • Has other contra-indications for transcranial magnetic stimulation (TMS) or Transcutaneous Spinal Cord Stimulation (TSCS).
  • Has a history of recent seizures or poorly managed autonomic dysreflexia that could be triggered by TMS or TSCS.
  • Has a history of prior intracranial surgery or known lesions that would limit TMS assessments and Brain-Computer Interface (BCI) recordings.
  • Individuals with metal implants in their head and other implantable devices in the body that could be affected by TMS or TSCS.
  • Has peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.).
  • Has urinary tract infection, unhealed fracture, contracture, and pressure sore (Braden Scale).
  • Has breakdown in skin area that will come into contact with electrodes.
  • Individuals who require therapy or other care that could interfere with participation in the study.
  • Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
  • Individuals with substance disorders, including alcoholism and drug abuse.
  • Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
  • 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
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Miami — Miami

Идентификаторы

NCT: NCT06406855 · 20240091

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗