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Идёт набор NCT06276634

Intermittent Hypoxia in Persons With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis Multiple Sclerosis-Relapsing-Remitting Multiple Sclerosis, Secondary Progressive

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: Acute Intermittent Hypoxia, Sham-Acute Intermittent Hypoxia.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Multiple Sclerosis-Relapsing-Remitting, Multiple Sclerosis, Secondary Progressive. 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
США
Следующий шаг
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Официальное название

Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis

Обзор

This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.

Подробное описание

Recent research has shown that AIH, characterized by brief episodes of reduced oxygen levels in the inspired air, has the potential to induce neural adaptations. These adaptations are suspected to influence several aspects of neuroplasticity, including the modulation of neurotransmitters and neurotrophic factors. Persons with MS typically exhibit greater cortical activation to achieve a given motor task compared to healthy controls, suggesting compensatory activations in motor cortices and the recruitment of additional non-motor regions for successful motor control. Therefore, interventions that promote adaptive neuroplasticity in motor control systems may induce a reduction in fMRI activation during motor tasks as well as an increase in functional connectivity between somatomotor cortices. This study will explore potential mechanisms of this intervention in MS using motor task performance and advanced neuroimaging techniques.

Вмешательства

  • Другое Acute Intermittent Hypoxia
    During each AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the AIH intervention. The AIH intervention involves alternating breathing cycles: one with lower oxygen concentration (9-10% Oxygen) than that at sea level (\~21% Oxygen) lasting between 30 and 60 seconds, followed by a similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.
  • Другое Sham-Acute Intermittent Hypoxia
    During each Sham-AIH session, the participant will be equipped with a non-rebreathing face mask, and provided with the Sham-AIH intervention. The Sham-AIH intervention involves alternating breathing cycles: both with oxygen concentrations of \~21% Oxygen lasting between 30 and 60 seconds, followed by another similar duration of normal room air (21% Oxygen). This cycle will be repeated 15 times in one session, continuous blood oxygen levels and heart rate will be monitored.

Первичные конечные точки

  • Ankle Plantarflexion Strength [Срок оценки: Before and following each 5-day intervention block]
Вторичные конечные точки (1)
  • Task fMRI [Срок оценки: Before and following each 5-day intervention block]

Критерии участия

Критерии включения

  • Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)
  • Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5
  • Motor Functional System Scale (FSS) between 2-4
  • Relapse free for at least 1 year
  • Age ≥ 18 years and ≤ 75 years
  • Safe to be scanned based on MRI questionnaire
  • Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

Критерии исключения

  • Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan
  • Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)
  • History of epilepsy
  • Chronic obstructive pulmonary disease
  • Uncontrolled Sleep apnea
  • Pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Shirley Ryan AbilityLab — Chicago

Идентификаторы

NCT: NCT06276634 · STU00219535 · R21HD108587

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗