Examining the Relationship Between Changes in Corticospinal Excitability and Motor Learning After Acute Intermittent Hypoxia in Able-bodied Individuals for Subsequent Study in Individuals With Incomplete Spinal Cord Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Change in Corticospinal Excitability
研究概览
简要总结
The goal of this study is to examine the effect of repetitive acute intermittent hypoxia on motor learning abilities in able-bodied individuals for subsequent study in individuals with incomplete spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 70 years old (the latter to reduce likelihood of heart disease);
- •Medically stable with medical clearance from physician to participate;
- •Motor-incomplete spinal cord injuries at or below C2 and at or above L5;
- •AIS A-D at initial screen, or other non-traumatic spinal cord injury disorders (e.g. multiple sclerosis, ALS, tumors, acute transverse myelitis, etc.);
- •More than 1 year since iSCI to minimize confounds of spontaneous neurological recovery;
- •Ability to advance one step overground with or without assistive devices;
排除标准
- •Severe concurrent illness or pain;
- •Recurrent autonomic dysreflexia;
- •History of cardiovascular/pulmonary complications;
- •Concurrent physical therapy;
- •Pregnant at time of enrollment or planning to become pregnant;
- •Untreated painful musculoskeletal dysfunction, fracture or pressure sore;
- •History of seizures or epilepsy;
- •Recurring headaches;
- •Concussion within the last six months;
- •Depression or manic disorders
- •Metal implants in the head, or pacemaker.
研究组 & 干预措施
Control
The control group received no AIH exposure.
Repetitive Acute Intermittent Hypoxia
5 consecutive days of 15, 1.5 min episodes at 9% O2 (AIH) alternating with 21% O2 at 1 min intervals
干预措施: Acute Intermittent Hypoxia (Other)
SHAM Acute Intermittent Hypoxia
5 consecutive days of 15, 1.5 min episodes at 21% O2 (SHAM AIH) alternating with 21% O2 at 1 min intervals
干预措施: SHAM Acute Intermittent Hypoxia (Other)
结局指标
主要结局
Change in Corticospinal Excitability
时间窗: We will measure TMS before the start of 5 consecutive days of AIH or SHAM treatment. We will measure TMS within 24 hours of the final treatment.
Transcranial magnetic stimulation (TMS) can be applied over the primary motor cortex to examine changes in corticospinal excitability. The downstream muscle activation can be recorded with surface EMG as a motor-evoked potential (MEP). The peak-to-peak MEP amplitude (mV) is as an index of corticospinal excitability. A randomized sequence of TMS intensities can be applied over the primary motor cortex, ranging from 90-140% of the participants' resting motor threshold (RMT). The mean MEP amplitude will be plotted against the corresponding stimulation intensity to produce the recruitment curve. The area under the recruitment curve is an additional index of corticospinal excitability (mV/% RMT).
Step Length Asymmetry
时间窗: We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
Step length asymmetry will be quantified as the ratio of the normalized difference in step lengths between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step length) / (Fast leg + Slow leg step length).
Step Time Asymmetry
时间窗: We will compare asymmetry 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
Step time asymmetry will be quantified as the ratio of the normalized difference in step times between the fast and slow legs during split-belt motor adaptation: (Fast leg - Slow leg step time) / (Fast leg + Slow leg step time).
Net Metabolic Power
时间窗: We will compare net metabolic power 15 minutes after the final AIH treatment to asymmetry following no treatment (control group).
Using expired gas analyses, we will calculate net metabolic power by inputting steady-state values for V̇O₂ and V̇CO₂ into standard regression equations (W), subtracting resting values, and normalizing the result to each participant's body weight (kg).
次要结局
未报告次要终点
研究者
Andrew Quesada Tan
Assistant Professor
University of Colorado, Boulder