Status:
ACTIVE_NOT_RECRUITING
Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
Foundation Wings For Life
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine how the nervous system controlling leg muscles is altered following spinal cord injury and how they may be affected by brief periods of low oxygen inhalation ...
Detailed Description
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 r...
Eligibility Criteria
Inclusion
- 18 to 75 years old (the latter to reduce likelihood of heart disease);
- medically stable with clearance from physician to participate;
- motor---incomplete SCI at C2---L5 with non---progressive etiology;
- \>6 months since SCI to ensure minimal confounds of spontaneous neurological recovery;
- those classified as ambulatory must have the ability to advance one step overground without human assistance.
Exclusion
- concurrent illness, including unhealed decubiti, severe neuropathic or chronic pain syndrome, infection, cardiovascular disease, osteoporosis (history of fractures), active heterotopic ossification, or known history of peripheral nerve injury to legs;
- less than 24 on the Mini-mental Exam;
- recurrent autonomic dysreflexia
- cardiopulmonary complications
- concurrent physical therapy
- pregnancy because of unknown effects of AIH on a fetus, although women will not otherwise be excluded
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02274116
Start Date
October 1 2014
End Date
November 1 2027
Last Update
October 31 2025
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States, 02138