BioFLO for Respiratory Recovery in SCI

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT06011876

Run by

University of Florida

People needed

62

Starts

2023-12-21

Expected to finish

2027-09-01

Last updated by the study team

2025-11-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18-70 years of age
• 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.
• Medically stable with physician clearance
• SCI due to non-progressive etiology
• 20% impairment in maximal inspiratory, maximal expiratory pressure generation, or both relative to normative values

You may not qualify if…

• Current diagnosis of an additional neurologic condition such as Multiple Sclerosis, Parkinson disease, stroke, or brain injury
• 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
• Severe neuropathic pain
• Known pregnancy
• 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 is running

• Brooks Rehabilitation — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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