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Идёт набор NCT05467215

Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?

Ранняя фаза I 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: Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408.
Кому может быть актуально
Состояния в реестре: Spinal Cord Injuries. Базовые параметры: 18 лет — 65 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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Обзор

This proof-of-principle study will determine if breathing an increased concentration of oxygen above the concentration in normal room air results in changes in the sensory and motor function in people with subacute or chronic, severe spinal cord injury (SCI).

Подробное описание

This proof-of-principle study will include a small number of participants with subacute or chronic (\>3 months post-injury), severe spinal cord injury (i.e., AIS A, B or C). After screening for potential contraindications, participants will attend 4 experimental sessions. In each session, their sensory or reflex function will be tested at regular intervals. Once baseline recordings are established, participants will be given either room air or 99% oxygen to breathe through a face mask for 2 minutes. It will be determined if breathing 99% oxygen results in a change in the sensory and motor functions recorded before and shortly after breathing oxygen.

Administration of a high concentration of oxygen at atmospheric pressure for a short duration has been completed without adverse effects in healthy individuals, and individuals with various forms of injury including chronic obstructive lung disease, traumatic brain injury, stroke, and spinal cord injury. Duration of administration has ranged from 3 min to 4 hours without adverse effects.

If this initial trial indicates that improvements in sensory and motor function are induced by this short exposure, exploration of therapeutic ways to increase blood flow to the spinal cord will be undertaken

Вмешательства

  • Препарат Pure oxygen (99%) from Praxair, Edmonton, DIN# 02014408
    Participants will receive oxygen (99%) or room air (placebo) delivered through a face mask at a flow rate of 10 litres/min for 2 minutes. The participants will be exposed twice to both conditions over 4 experiments at a minimum of 2 week intervals between each testing session.

Первичные конечные точки

  • Skin Sensation [Срок оценки: Pre-intervention (exposure to high oxygen)]
  • Skin Sensation [Срок оценки: Immediately after intervention (exposure to high oxygen)]
  • Skin Sensation [Срок оценки: Pre-intervention (exposure to room air)]
  • Skin Sensation [Срок оценки: Immediately after intervention (exposure to room air)]
Вторичные конечные точки (4)
  • Reflex Excitability [Срок оценки: Pre-intervention (exposure to high oxygen)]
  • Reflex Excitability [Срок оценки: Immediately after intervention (exposure to high oxygen)]
  • Reflex Excitability [Срок оценки: Pre-intervention (exposure to room air)]
  • Reflex Excitability [Срок оценки: Immediately after intervention (exposure to room air)]

Критерии участия

Критерии включения

  • Individuals with traumatic SCI with onset ≥3 months prior,
  • Between 18 - 65 yr old,
  • ASIA Impairment Scale at discharge classified as A, B or C,
  • Injury level between C5 and T10,
  • Able to give informed, written consent.

Критерии исключения

  • Frequent uncontrolled autonomic dysreflexia,
  • Uncontrolled high blood pressure,
  • Cardiac or cardiovascular disease,
  • Cancer,
  • Active urinary tract infection,
  • Active pressure sores,
  • Signs of deep vein thrombosis in the legs,
  • Severe swelling of the feet and/or legs,
  • Severe cognitive impairment,
  • Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection,
  • Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain
  • Pregnancy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Канада · 1 центр
  • University of Alberta, Clinical Sciences Bldg — Edmonton

Идентификаторы

NCT: NCT05467215 · Pro00061817

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗