BioFLO for Respiratory Recovery in SCI
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:
🦠 Spinal Cord Injuries
🗓️ Study Start (Actual) 21 December 2023
🗓️ Primary Completion (Estimated) July 2027
✅ Study Completion (Estimated) September 2027
👥 Enrollment (Estimated) 62
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Jacksonville, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Adults 18-70 years of age
    • * Chronic SCI for \> 1 year, at or below C-3 to T-12
    • * Incomplete SCI based on residual sensory or 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
    • * Medically stable with physician clearance
    • * SCI due to non-progressive etiology
    • * 20% impairment in maximal inspiratory or expiratory pressure generation, relative to normative values

    Exclusion Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 August 2023
  • First Submitted that Met QC Criteria 24 August 2023
  • First Posted 25 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 January 2024
  • Last Update Posted 3 January 2024
  • Last Verified January 2024