The Effects of Intermittent Hypoxia on Leg Function in Human Spinal Cord Injury (Caffeine Substudy)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 10 Meter Walk Time
研究概览
简要总结
Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand how caffeine may augment the effects of intermittent hypoxia on motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.
详细描述
The investigators will examine the effects of acute intermittent hypoxia (AIH) as a possible therapeutic intervention to promote functionally useful motor recovery. In this sub-study, the investigators will assess changes in leg motor function in response to repetitive AIH with and without caffeine.
Participants will receive caffeine+AIH, placebo+AIH, caffeine+SHAM in a randomized order. Before each intervention round, subjects will be asked to avoid caffeine-containing substances for 48 hrs (> 5* half-life of ~7 hrs) prior to arrival to control for baseline plasma levels of caffeine. Subjects will then ingest capsules containing either placebo (dextrose) or caffeine (up to 6mg/kg). Capsules will be prepared by Johnson Compounding & Wellness. Blood samples will be collected before and after the breathing intervention to assess caffeine concentrations within the body.
During and after each intervention, both the rate and extent of magnitude changes in voluntary and involuntary muscle response behaviors important for walking will be compared between interventions within participants. Repeated measurements will be collected on all subjects that participate in the multiple interventions.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- 是
入选标准
- •age 18 and 75 years (the latter to reduce likelihood of heart disease)
- •medical clearance to participate
- •lesion at or below C2 and above L5 with non-progressive etiology
- •classified as motor-incomplete with visible volitional leg movement
- •injury greater than 6 months
- •ability to advance one step overground without human assistance
排除标准
- •Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
- •Pregnant women because of the unknown affects of AIH on pregnant women and fetus
- •History of seizures, brain injury, and/or epilepsy
- •Undergoing concurrent physical therapy
- •Cirrhosis
- •Caffeine and/or NSAID allergies or intolerances
研究组 & 干预措施
Caffeine/AIH
Subjects with chronic, motor-incomplete SCI receive Caffeine then AIH
干预措施: Caffeine (Drug)
Caffeine/AIH
Subjects with chronic, motor-incomplete SCI receive Caffeine then AIH
干预措施: AIH (Other)
Placebo/AIH
Subjects with chronic, motor-incomplete SCI receive Placebo then AIH
干预措施: AIH (Other)
Placebo/AIH
Subjects with chronic, motor-incomplete SCI receive Placebo then AIH
干预措施: Placebo (Other)
Caffeine/SHAM
Subjects with chronic, motor-incomplete SCI receive Caffeine then SHAM
干预措施: Caffeine (Drug)
Caffeine/SHAM
Subjects with chronic, motor-incomplete SCI receive Caffeine then SHAM
干预措施: SHAM (Other)
结局指标
主要结局
10 Meter Walk Time
时间窗: Baseline, after intervention (day 5), and at follow-ups (one week and two weeks)
Speed will be assessed using the time required to walk 10 meters (10MWT) relative to baseline.
次要结局
- 6 Minute Walk Test(Baseline, after intervention (day 5), and at follow-ups (one week and two weeks))
研究者
Randy Trumbower, PT, PhD
Assistant Professor
Spaulding Rehabilitation Hospital