Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Ankle Plantarflexion Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Ankle Plantarflexion Strength
时间窗: Before and following each 5-day intervention block
Participants will be seated in an adjustable chair with tested foot secured to a foot plate with the ankle in line with a rotational load cell. Participants will be asked to produce maximal ankle plantarflexion contractions, Electromyographic signals of the gastrocnemius, tibialis anterior, and soleus will be recorded simultaneously
次要结局
- Task fMRI(Before and following each 5-day intervention block)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab