BioFLO for Respiratory Recovery in SCI
Eligible age
18–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Florida
You may qualify if…
- ✓ 1. Adults 18-70 years of age
- ✓ 2. Chronic incomplete SCI ≥ 1 year at or below C1-T12
- ✓ 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 ≥1 year at or below C4-T12
- ✓ 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.
- ✓ 3. Medically stable with physician clearance
- ✓ 4. SCI due to non-progressive etiology
- ✓ 5. 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values
You may not qualify if…
- ✕ 1. Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
- ✕ 2. Severe illness or infection, including non-healing decubitus ulcers, untreated bladder or urinary tract infections, cardiovascular disease, lung disease, active heterotopic ossification, or uncontrolled hypertension
- ✕ 3. Severe neuropathic pain
- ✕ 4. Known pregnancy
- ✕ 5. Severe recurrent autonomic dysreflexia
- ✕ Exclusion for involvement in TMS - History of seizure disorder, uncontrolled migraines, presence of cardiac pacemaker, metal implants in skull, medications that lower seizure threshold.
Where it's recruiting
Jacksonville
Source: ClinicalTrials.gov · NCT06011876 · last updated 2025-11-05