FLO2 for Recovery After SCI

Completed · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injury (SCI)

In brief

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 function after spinal cord injury (SCI). This study will use a double blind, cross-over design to test if the combination of AIH and respiratory strength training improves breathing function more than either approach alone in adults with chronic SCI.

Key facts

Study ID

NCT03833674

Run by

University of Florida

People needed

43

Starts

2020-08-15

Expected to finish

2024-02-20

Last updated by the study team

2024-05-29

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brooks Rehabilitation Hospital — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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