Spinal Cord Injury Clinical Trial
Official title:
Intermittent Hypoxia Promotes Restoration of Hand Function Following SCI
Verified date | January 2016 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 53 |
Est. completion date | October 2015 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory Center for Rehabilitation Medicine | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | University of Saskatchewan, University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hand grasp | 1 week | No | |
Secondary | Grip strength | 1 week | No |
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