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Идёт набор NCT06596369

Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

Фаза II / Фаза III С лечением Spinal Cord Injuries Stroke

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, Upper extremity rehabilitation.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Stroke. 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
Канада
Следующий шаг
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Официальное название

Transcutaneous Spinal Cord Stimulation to Facilitate Recovery of Upper Extremity Function in Individuals With Stroke or Spinal Cord Injury - A Pilot Study

Обзор

Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke. However, the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm. Additionally, the utility of noninvasive tcES in the stroke population remains unexplored. This project utilizes a comprehensive set of neurophysiological techniques, in combination with carefully chosen motor tasks, to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke. The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function.

Подробное описание

In the first two aims of this study we explore the effects of stimulation configurations on neural excitability. Specifically we will explore the effects of electrode placement and stimulation frequency on measures of corticospinal and intracortical excitability. In the last aim of this study, individuals will participate in an interventional trial combining activity-based therapy with tcES. We will explore whether this intervention facilitated improvements in upper extremity function through clinical and neurophysiological assessments.

Вмешательства

  • Устройство Transcutaneous spinal cord stimulation
    Continuous, sub motor threshold stimulation is delivered through surface electrodes placed over the cervical spine region.
  • Другое Upper extremity rehabilitation
    Using the ReJoyce system individuals will engage in upper extremity rehabilitation.

Первичные конечные точки

  • Spinal Excitability [Срок оценки: Baseline, End of Intervention (2mths), 6-month follow-up (8mths)]
  • Corticospinal excitability [Срок оценки: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)]
  • Clinical assessment of UE function [Срок оценки: Baseline, End of Intervention (2mths), and 6-month Follow-up (8mths).]
  • Changes in Intracortical Excitability [Срок оценки: Baseline, End of Intervention (2mths) and at 6-month follow-up timepoint (8mths)]

Критерии участия

Критерии включения

SCI cohort:

  • individuals aged 18 to 75 years of age who have suffered a spinal cord injury
  • cervical level injury (C3 to C8)
  • at least 1-year post-injury
  • for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening

Stroke cohort:

  • individuals aged 18-75 years of age who have suffered any type of stroke resulting in upper extremity motor dysfunction with partially preserved motor function
  • ≥ 6 months post-stroke
  • At least 4 months since last BoNT injection for treatment of spasticity or any other condition or ≤ 2 months after study completion
  • for individuals taking medications for spasmolysis or muscle relaxation (e.g. oral baclofen, tizanidine, dantrolene, vigabatrin, gabapentin, or benzodiazepine), dose and regimen must be stable for at least 4 weeks prior to screening

Критерии исключения

  • pregnant women
  • aphasia or dysphasia
  • spasticity grade Modified Ashworth Scale ≥ 3

Transcranial magnetic stimulation-specific exclusion criteria (both cohorts)

  • participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
  • participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
  • participants with a history of seizures or epilepsy
  • participants taking any medication which may reduce seizure threshold

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

Канада · 2 центра
  • Glenrose Rehabilitation Hospital — Edmonton
  • University of Alberta — Edmonton

Идентификаторы

NCT: NCT06596369 · Pro001405596

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗