Investigating the Effects of Acute Intermittent Hypoxia on Neuroplasticity in Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Threshold For Detecting Passive Joint Movement
研究概览
简要总结
This study seeks to explore changes in the neural pathways and arm function following a breathing intervention in the multiple sclerosis (MS) population. The breathing intervention, known as Acute Intermittent Hypoxia (AIH), involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. Here, the study examines arm and hand function before and after AIH. In order to better understand the brain and spinal cord response to AIH, the investigators will measure muscle response, and signals sent from the brain to the arm muscles before and after AIH.
详细描述
While AIH has shown potential in enhancing neuroplasticity in people with spinal cord injury (SCI), it has yet to be studied extensively in MS. Preliminary research in the MS population demonstrates that a single session of AIH enhances motor output, increasing voluntary muscle strength by as much as 15-20% within 60 minutes. This study will explore potential mechanisms of AIH in MS using measurements of arm function, as well as examination of corticospinal and spinal motoneuron excitability.
Over the past decade, studies have found that brief episodes of modest oxygen reduction (termed AIH) can rapidly enhance neural plasticity in persons with incomplete SCI. AIH activates the serotonergic pathway, leading to increased activity of serotonin receptors and the synthesis of plasticity-related proteins. This plasticity is manifested by a rapid increase in voluntary muscle strength, emerging within 60-90 minutes, in both lower- and upper-limb muscles. The actions of AIH appear to be biologically linked to systems designed to preserve breathing systems that are impaired by damage to the central nervous system (CNS).
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
- •Diagnosis of relapsing-remitting MS according to the McDonald criteria, over 5 years ago
- •Relapse free for at least 6 months
- •Expanded Disability Status Scale (EDSS) ≤7
- •Index finger abduction strength <5 according to Medical Research Council Scale, or 9-Hole Peg Test score >20 seconds in at least one hand
- •Stable disease modifying therapies for at least 6 months
- •Individuals taking dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening
排除标准
- •Another diagnosis (e.g., peripheral neuropathies or orthopedic) affecting upper limb function
- •Mini-Mental State Examination (MMSE) score <24
- •Modified Ashworth Scale score >3 on elbow joint
- •Uncontrolled hypertension or hypotension (outside 140/90 and 85/55 mmHg)
- •History of epilepsy, chronic obstructive pulmonary disease, or sleep apnea
- •Unstable medical conditions, ongoing upper limb therapy, or musculoskeletal pain
- •Pregnancy as confirmed by urine test
研究组 & 干预措施
AIH first
Participants in the first arm will undergo 2 sessions of AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of Sham AIH also separated by a 1-week washout period.
干预措施: Acute Intermittent Hypoxia (Other)
AIH first
Participants in the first arm will undergo 2 sessions of AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of Sham AIH also separated by a 1-week washout period.
干预措施: Sham Acute Intermittent Hypoxia (Other)
Sham First
Participants in the this arm will undergo 2 sessions of Sham AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of AIH also separated by a 1-week washout period.
干预措施: Acute Intermittent Hypoxia (Other)
Sham First
Participants in the this arm will undergo 2 sessions of Sham AIH each separated by a 1-week washout period. 1 week later, participants will undergo 2 sessions of AIH also separated by a 1-week washout period.
干预措施: Sham Acute Intermittent Hypoxia (Other)
结局指标
主要结局
Threshold For Detecting Passive Joint Movement
时间窗: Immediately before the intervention and immediately after the intervention.
An assisted movement with enhanced sensation (AMES) will be used to rotate the participant's joint. The difference between the reference and matching joint angles is used to measure joint position sense. The investigators will present three target positions, and subjects will perform ipsilateral matching for each target 5 times.
Accuracy of Direction Estimation of Passive Joint Movement
时间窗: Immediately before the intervention and immediately after the intervention.
An AMES will be used to rotate the participant's joint. The difference between the reference and matching joint angles is used to measure joint position sense. The investigators will present three target positions, and subjects will perform ipsilateral matching for each target 5 times.
Motor Evoked Potentials (MEPs) in First Dorsal Interosseous (FDI)
时间窗: Immediately before, immediately after, and 60 minutes after the intervention.
The MEPs will be elicited by Transcranial Magnetic Stimulation (TMS), a procedure that uses magnetic fields to stimulate nerve cells in the brain.
Changes in Spinal Reflex Threshold
时间窗: Immediately before the intervention and immediately after the intervention.
Spinal reflect threshold will be measured by calculating the average change in threshold length recorded from the biceps tendon's indentation. A linear motor will be used to impose precise tendon indentations of the biceps brachii.
次要结局
- Grip Strength(Immediately before the intervention and immediately after the intervention.)
- Pinch Strength(Immediately before the intervention and immediately after the intervention.)
- Symbol Digit Modalities Test(Immediately before the intervention and immediately after the intervention.)
- Box and Block Test(Immediately before the intervention and immediately after the intervention.)
- Index Finger Abduction Force(Immediately before the intervention and immediately after the intervention.)
- Nine-Hole Peg Test(Immediately before the intervention and immediately after the intervention.)
- Modified Ashworth Scale(Immediately before the intervention and immediately after the intervention.)
- Ipsilateral Joint Position Matching Task(Immediately before the intervention and immediately after the intervention.)
- Visual Analog Pain Scale(Immediately before the intervention and immediately after the intervention.)
研究者
Milap Sandhu
Principal Investigator
Shirley Ryan AbilityLab