Actively Recruiting
Hypoxia Pathways for Early Recovery After Spinal Cord Injury
Led by University of Florida · Updated on 2025-12-03
18
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
B
Brooks Rehabilitation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, diminishing breathing capacity and airway defense (e.g., cough). Indeed, respiratory impairment is a leading cause of infection, re-hospitalization and death after SCI. There is a critical need for new strategies to restore breathing ability and airway defense in people with SCI. Acute intermittent hypoxia (AIH) - repetitive exposure to brief episodes of low inspired oxygen - is a promising strategy to restore breathing capacity by promoting spinal neuroplasticity. Exciting outcomes in \>12 SCI trials completed to date demonstrate that AIH improves human respiratory and limb function. Unfortunately, \~40% of individuals exhibit minimal response to AIH, making it essential to 1) optimize AIH protocols to maximize functional benefits; and 2) identify genetic biomarkers distinguishing those most/least likely to benefit from AIH-based treatments. The purpose of the pilot study, to be conducted in a small sample of participants with sub-acute SCI (2 weeks to 6 months post injury), is to preliminarily compare the effects of two intermittent hypoxia protocols. Since AIH-induced plasticity may be induced via serotonin or adenosine-driven mechanisms and these pathways compete and inhibit each other, each protocol favors a distinct mechanistic pathway. Our long-term objective is to test the hypothesis that a longer duration (i.e., augmented) hypoxia protocol, favoring adenosine mechanisms, enhances respiratory motor plasticity more than an AIH protocol targeting serotonin mechanisms (low O2 + CO2) in people with sub-acute SCI. Since an individual's genetics can influence the response to rehabilitation, we are also investigating how certain genes are related to breathing changes after these treatments. Data acquired through this pilot study will be used to inform a larger, more definitive clinical trial and will contribute to estimations of the magnitude and direction of effects.
CONDITIONS
Official Title
Hypoxia Pathways for Early Recovery After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 70 years old
- Sub-acute spinal cord injury 2 weeks to 6 months after injury
- Incomplete SCI at or below C1 to T6 with some residual sensory and motor function, or complete SCI at or below C4 to T6 without residual function
- Medically stable with doctor clearance
- Spinal cord injury caused by a non-progressive condition
You will not qualify if you...
- Diagnosis of other neurological conditions such as Multiple Sclerosis, Parkinson's disease, stroke, or brain injury
- Severe illness or infection including non-healing wounds, untreated bladder or urinary infections, cardiovascular or lung disease, active heterotopic ossification, or uncontrolled high blood pressure
- Severe neuropathic pain
- Known pregnancy
- Severe uncontrolled autonomic dysreflexia
- Currently hospitalized in an acute care hospital
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216
Actively Recruiting
Research Team
E
Emily J Fox, PT, DPT, MHS, PhD
CONTACT
H
Hannah J Snyder, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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