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临床试验/NCT01272336
NCT01272336已完成1 期

Intermittent Hypoxia Promotes Restoration of Hand Function Following SCI

Emory University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
53
试验地点
1
主要终点
Hand grasp

研究概览

简要总结

The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).

详细描述

The goal of the study is to examine the effects of repeated breathing episodes of mild intermittent hypoxia (reduced oxygen) training on hand strength and grasping ability following cervical spinal injury, and to determine whether these changes result in improved hand function. If so, such changes may indicate hypoxia-induced spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences), which could result in improvements in hand use for persons with spinal cord injury (SCI).

This idea stems from animal studies on respiration, in which investigators have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections within the spinal cord by a mechanism known as respiratory long-term facilitation. Exposure to mild hypoxia triggers oxygen sensors in the nervous system resulting in a cascade of events, including increased production of key proteins and, increased sensitivity of spinal cord circuitry necessary for improved respiration.

Because previous work using animal models has shown that similar events occur along non-respiratory pathways, the investigators propose to investigate whether a comparable dosing scheme of daily, mild intermittent hypoxia can positively affect upper limb function in persons with cervical SCI.

First, the investigators hypothesize that daily exposure of intermittent hypoxia training (7 consecutive days) will result in a sustained improvement in rat forelimb function that is dose-dependent. To test this hypothesis, the investigators will quantify the effects of variations in the number of intermittent hypoxia episodes on forelimb function in cervical spinal injured rats.

Second, the investigators hypothesize that daily exposure of intermittent hypoxia training will improve hand function in persons with cervical spinal injury. To test this hypothesis, the investigators will quantify the effect of mild intermittent hypoxia exposure, using a protocol derived from the animal model, on volitional grip strength and grasp function in persons with cervical SCI.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •age 18 and 65 years
  • •medical clearance to participate
  • •lesion below the 5th cervical spinous process (C5) and above the first thoracic spinous process (T1) with non-progressive etiology
  • •classified as motor-incomplete injury greater than 12 months
  • •independent breathing

排除标准

  • •Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of cardiac or pulmonary complications)
  • •Pregnant women because of the unknown affects of acute intermittent hypoxia on pregnant women and fetus
  • •Concomitant acquired brain injury
  • •History of seizures, brain injury, and/or epilepsy
  • •Diagnosed with obstructive sleep apnea
  • •Undergoing concurrent physical therapy
  • •Any contraindications to EMG testing procedures (skin sensitivity)
  • •Any contraindications to passive movement of the limbs
  • •Score of < 24 on Mini-Mental Exam

研究组 & 干预措施

AIH/Sham

Active Comparator

Subjects with chronic, motor-incomplete SCI receive AIH and then SHAM

干预措施: Acute Intermittent Hypoxia (AIH) (Drug)

AIH/Sham

Active Comparator

Subjects with chronic, motor-incomplete SCI receive AIH and then SHAM

干预措施: SHAM-Intermittent Room Air (Other)

Sham/AIH

Active Comparator

Subjects with chronic, motor-incomplete SCI receive SHAM and then AIH

干预措施: Acute Intermittent Hypoxia (AIH) (Drug)

Sham/AIH

Active Comparator

Subjects with chronic, motor-incomplete SCI receive SHAM and then AIH

干预措施: SHAM-Intermittent Room Air (Other)

结局指标

主要结局

Hand grasp

时间窗: 1 week

次要结局

  • Grip strength(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randy D. Trumbower

Assistant Professor

Emory University

研究点 (1)

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