Actively Recruiting
BioFLO for Respiratory Recovery in SCI
Led by University of Florida · Updated on 2025-11-05
62
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
U
U.S. Army Medical Research Acquisition Activity
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute intermittent hypoxia (AIH) involves brief (1 min), repeated episodes (\~15) of breathing low oxygen air to stimulate spinal neuroplasticity. Animal and human studies show that AIH improves motor function after spinal cord injury, particularly with slightly increased carbon dioxide (hypercapnic AIH; AIHH) and task-specific training. Using a double blind cross-over design, the study will test whether AIHH improves breathing more than AIH and whether specific genetic variations are related to individuals' intervention responses.
CONDITIONS
Official Title
BioFLO for Respiratory Recovery in SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 to 70 years of age
- Chronic incomplete spinal cord injury (SCI) of 1 year or more at or below C1-T12 with residual sensory and motor function or classified as B, C, D -OR- Chronic complete SCI of 1 year or more at or below C4-T12 with no sensory or motor function or classified as A
- Medically stable with physician clearance
- SCI caused by a non-progressive condition
- At least 20% impairment in maximal inspiratory or expiratory pressure compared to normal values
You will not qualify if you...
- Current diagnosis of additional neurological conditions such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
- Severe illness or infection including non-healing ulcers, untreated urinary tract infections, heart or lung disease, active heterotopic ossification, or uncontrolled high blood pressure
- Severe neuropathic pain
- Known pregnancy
- Severe recurrent autonomic dysreflexia
- For TMS involvement: history of seizure disorder, uncontrolled migraines, cardiac pacemaker, metal skull implants, or medications that lower seizure threshold
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216
Actively Recruiting
Research Team
E
Emily J Fox, PT, MHS, PhD
CONTACT
H
Hannah Snyder, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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