Status:
RECRUITING
BioFLO for Respiratory Recovery in SCI
Lead Sponsor:
University of Florida
Collaborating Sponsors:
U.S. Army Medical Research Acquisition Activity
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
This study will consist of two parts - single-session testing days, and respiratory strength training blocks. If a participant is not eligible to enroll in single-day testing, they will be asked to en...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06011876
Start Date
December 21 2023
End Date
September 1 2027
Last Update
November 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Brooks Rehabilitation
Jacksonville, Florida, United States, 32216