Status:
COMPLETED
FLO2 for Recovery After SCI
Lead Sponsor:
University of Florida
Collaborating Sponsors:
United States Department of Defense
Brooks Rehabilitation
Conditions:
Spinal Cord Injury (SCI)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Acute intermittent hypoxia (AIH) involves short (\~1-2min) bouts of breathing low oxygen air to stimulate spinal neuroplasticity. Studies in rodents and humans indicate that AIH improves motor functio...
Detailed Description
Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, causing muscle paralysis and decreased breathing capacity. Since respiratory impairment is the major cause of illness an...
Eligibility Criteria
Inclusion
- Chronic incomplete SCI for ≥ 1 year at or below C-1 to T-12
- Incomplete SCI based on residual sensory and motor function below the level of the injury or injury classification of B, C, D at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI
- OR-
- Chronic complete SCI for ≥ 1 year at or below C-4 to T-12
- Complete SCI based on the absence of residual sensory or motor function below the level of injury or injury classification of A at initial screening according to the American Spinal Injury Association Impairment Classification and the International Standards for the Neurological Classification of SCI.
- Medically stable with clearance from physician
- SCI due to non-progressive etiology
- \>20% impairment in maximal inspiratory or expiratory pressure generation, relative to established normative values.
Exclusion
- Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
- Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction, \<1 year lung disease, infections, hypertension, heterotopic ossification.
- Severe neuropathic pain
- Known pregnancy
- Severe recurrent autonomic dysreflexia
- History of seizure disorder \< 1 year
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03833674
Start Date
August 15 2020
End Date
February 20 2024
Last Update
May 29 2024
Active Locations (1)
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1
Brooks Rehabilitation Hospital
Jacksonville, Florida, United States, 32216