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Идёт набор NCT06330181

Virtual Walking Therapy for Neuropathic Pain Following Incomplete Spinal Cord Injury

Без фазы С лечением Spinal Cord Injuries Neuropathic Pain

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: VR Game 1, VR Game 2.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries, Neuropathic Pain. 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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Обзор

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with incomplete spinal cord injury.

Подробное описание

Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job of reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mismatch' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking may potentially reduce this 'mismatch' by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that make neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as incomplete (ASIA B, C, or D).

Вмешательства

  • Другое VR Game 1
    Individuals playing VR game 1 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. A
  • Другое VR Game 2
    Individuals playing VR game 2 will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective. Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. A

Первичные конечные точки

  • Change in Pain Intensity [Срок оценки: Baseline - final follow up (up to 18 months)]
Вторичные конечные точки (6)
  • Change in Pain Quality [Срок оценки: Baseline - final follow up (up to 18 months)]
  • Change in Pain Interference [Срок оценки: Baseline - final follow up (up to 18 months)]
  • Post treatment change [Срок оценки: at follow up (up to 18 months)]
  • Change in mood [Срок оценки: Baseline - final follow up (up to 18 months)]
  • Change in quality of life [Срок оценки: Baseline - final follow up (up to 18 months)]
  • Neurological changes [Срок оценки: Baseline - 6 months]

Критерии участия

Критерии включения

The study will recruit individuals with incomplete injury (American Spinal Injury Association \[ASIA\] classification B, C, or D) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:

  • Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
  • Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
  • Must be 18 years of age or older
  • Must be more than one and a half years post-injury to begin study (can be screened at an earlier time for eligibility)
  • Must have mobile connectivity with usable service
  • Must be stable on pain medication for 1 or more months
  • Must be cleared on the VRWalk physical activity clearance scale
  • Must not have motion sickness that interferes with daily life
  • Must use a wheelchair at least 75% of the time

Критерии исключения

  • Individuals with Injury levels between C1 and C4
  • Individuals under the age of 18
  • Individuals who were injured within the past year
  • Individuals who cannot comprehend spoken English
  • Individuals who are in prison
  • Individuals who are blind
  • Individuals who experience severe motion sickness

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Texas A&M University — College Station

Идентификаторы

NCT: NCT06330181 · SC220178 · HT9425-23-1-1019 · SC220178

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗