Examining the Effect of Acute Intermittent Hypoxia on Serum Blood Proteins, Corticospinal Excitability, and Force Control in Persons With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Serum Blood Brain Derived Neurotrophic Factor
研究概览
简要总结
The goal of this study is to clarify mechanisms of acute intermittent hypoxia and to examine the effect on lower limb function in persons with chronic, incomplete spinal cord injury.
详细描述
The goal of this study is to clarify mechanisms of acute intermittent hypoxia by examining changes in blood biomarkers, neural excitability, and hemoglobin mass. We also aim to clarify how these changes relate to changes in lower limb function in persons with chronic, incomplete spinal cord injury by measuring force steadiness and voluntary muscle activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 to 75 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 disorder
- •Metal implants in the head, or pacemaker
- •Aversion to needles
研究组 & 干预措施
AIH Group
Participants will be exposed to 4 consecutive days of acute intermittent hypoxia (AIH): 15, 1.5 min episodes at 9% O2 alternating with 21% O2 at 1 min intervals.
干预措施: Acute Intermittent Hypoxia (AIH) (Other)
SHAM Group
Participants will be exposed to 4 consecutive days of normoxia: 15, 1.5 min episodes at 21% O2 alternating with 21% O2 at 1 min intervals.
结局指标
主要结局
Change in Serum Blood Brain Derived Neurotrophic Factor
时间窗: Baseline, Day 1, Day 3, and Day 4
Serum blood brain derived neurotrophic factor (pg/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Change in Serum Serotonin
时间窗: Baseline, Day 1, Day 3, and Day 4
Serum serotonin (ng/mL) be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
Change in the Transcranial Magnetic Stimulation Recruitment Curve Slope
时间窗: Baseline and Day 4
The mean motor evoked potential response will be plotted against the corresponding stimulation intensity (% resting motor threshold) to produce a stimulus-response curve at 20% and 40% of maximum. We will measure TMS before the start of 4 consecutive days of AIH exposure. We will measure TMS within 24 hours of the final AIH exposure.
Change in Force Steadiness
时间窗: Baseline and Day 4
The coefficient of variation of force will be calculated in both plantarflexion and dorsiflexion at 20% and 40% of maximum. We will measure coefficient of variation of force before the start of 4 consecutive days of AIH exposure. We will measure coefficient of variation of force within 24 hours of the final AIH exposure.
Change in Central Activation Ratio
时间窗: Baseline and Day 4
We will measure the central activation ratio using supramaximal electrical stimulus over a peripheral nerve during maximum voluntary activation. We will measure the central activation ratio before the start of 4 consecutive days of AIH exposure. We will measure the central activation ratio within 24 hours of the final AIH exposure.
Change in hemoglobin mass
时间窗: Baseline and Day 4
Using the optimized carbon monoxide rebreathing procedure we will evaluate hemoglobin concentration, carboxyhemoglobin, and hematocrit to calculate total hemoglobin mass, blood volume, and plasma volume. The optimized carbon monoxide rebreathing procedure will be done prior to the first hypoxia exposure and following the 4th hypoxia exposure.
Change in Serum Erythropoetin
时间窗: Baseline, Day 1, Day 3, and Day 4
Serum erythropoetin (mU/mL) will be assessed using enzyme-linked immunosorbent assay. Blood will be sampled prior to AIH and within 1 hour following the 1st, 3rd, and 4th AIH exposure.
次要结局
- Axial damage ratio(Baseline)
- 6-Minute Walk Test(Baseline and Day 4)
- 10-Meter Walk Test(Baseline and Day 4)
研究者
Andrew Quesada Tan
Assistant Professor
University of Colorado, Boulder