Меню
Набор скоро начнётся NCT07562113

Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery

Фаза I / Фаза II С лечением Spinal Cord Injuries (Complete and Incomplete)

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: Transauricular vagus nerve stimulation.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries (Complete and Incomplete). Базовые параметры: 18 лет — 89 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation

Обзор

This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI). This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility. This study has two main goals: 1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury. 2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started. This study has two parts. In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel. In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.

Вмешательства

  • Устройство Transauricular vagus nerve stimulation
    bilateral transauricular vagal nerve stimulation

Первичные конечные точки

  • Phase 1 Hypotension Symptoms Immediately before taVNS is applied [Срок оценки: Immediately before Phase 1 taVNS application]
  • Phase 1 Hypotension Symptoms during taVNS spplication [Срок оценки: During application of Phase 1 taVNS]
  • Phase 1 Hypotension Symptoms Immediately after taVNS is stopped [Срок оценки: Immediately after Phase 1 taVNS is stopped]
  • Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped [Срок оценки: 5 minutes after Phase 1 taVNS is stopped]
  • Phase 1 taVNS Tolerability survey [Срок оценки: Within 48 hours of competing Phase 1 taVNS]
  • Phase 2 taVNS Tolerability survey [Срок оценки: Within 48 hours of completing Phase 2 taVNS]
Вторичные конечные точки (6)
  • Phase 1 Blood Pressure Immediately before taVNS is applied [Срок оценки: Immediately before taVNS Phase 1 application is applied]
  • Phase 1 Blood Pressure during taVNS application [Срок оценки: During taVNS Phase 1 application]
  • Phase 1 Blood Pressure Immediately after taVNS is stopped [Срок оценки: Immediately after taVNS Phase 1 application is stopped]
  • Phase 1 Blood Pressure 5 minutes after taVNS is stopped [Срок оценки: 5 minutes after taVNS Phase 1 application is stopped]
  • Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission [Срок оценки: Admission to rehabilitation]
  • Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge [Срок оценки: Immediately after discharge from rehabilitation]

Критерии участия

Критерии включения

  • Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)
  • Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan

Критерии исключения

  • Phase 1 Age >89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants
  • Phase 2 no exclusion criteria for those who meet inclusion criteria

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

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT07562113 · IRB-300015896 · UAB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗