Intermittent Hypoxia Elicits Prolonged Restoration of Motor Function in Human SCI
Completed · Phase 1
Conditions studied: Spinal Cord Injury
In brief
The goal of the study is to determine whether repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) will improve limb function after spinal cord injury. This idea stems from animal studies on respiration, in which investigators have shown that mild intermittent hypoxia improves breathing in spinally injured rats. These studies have shown that intermittent hypoxia induces spinal plasticity, strengthening neural connections and motor neuron function within the spinal cord. Exposure to mild intermittent hypoxia triggers a cascade of events, including increased production of key proteins and increased sensitivity of spinal cord circuitry necessary for improved breathing. The ultimate goal of this research is to assess the potential of mild intermittent hypoxia as a therapeutic approach to stimulate recovery of limb function in human patients.
Key facts
- Study ID
- NCT01272349
- Run by
- Emory University
- People needed
- 19
- Starts
- 2010-12-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2013-11-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- medical clearance to participate
- lesion below C5 and above T12 with non-progressive etiology
- classified as motor-incomplete
- injury greater than 12 months
- ambulatory with minimal assistance
You may not qualify if…
- 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 AIH on pregnant women and fetus
- 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 (e.g., joint immobility, hemodynamic instability)
- Score of < 24 on Mini-Mental Exam
Where it is running
- Shepherd Center — Atlanta, Georgia, United States
- Rehabilitation Institute of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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