Hypoxia Pathways for Early Recovery After Spinal Cord Injury (NCT07002437)
Intermittent Hypoxia-Induced Motor Plasticity in Sub-Acute Spinal Cord Injury
๐ฉบ Plain-English Summary (8th-Grade Level)
Spinal cord injury (SCI) disrupts neural pathways to respiratory motor neurons, diminishing breathing capacity and airway defense (e.g., cough). Indeed, respiratory impairment is a leading cause of infection, re-hospitalization and death after SCI. There is a critical need for new strategies to restore breathing ability and airway defense in people with SCI. Acute intermittent hypoxia (AIH) - repetitive exposure to brief episodes of low inspired oxygen - is a promising strategy to restore breathing capacity by promoting spinal neuroplasticity. Exciting outcomes in \>12 SCI trials completed to date demonstrate that AIH improves human respiratory and limb function. Unfortunately, \~40% of individuals exhibit minimal response to AIH, making it essential to 1) optimize AIH protocols to maximize functional benefits; and 2) identify genetic biomarkers distinguishing those most/least likely to benefit from AIH-based treatments. The purpose of the pilot study, to be conducted in a small sample of participants with sub-acute SCI (2 weeks to 6 months post injury), is to preliminarily compare the effects of two intermittent hypoxia protocols. Since AIH-induced plasticity may be induced via serotonin or adenosine-driven mechanisms and these pathways compete and inhibit each other, each protocol favors a distinct mechanistic pathway. Our long-term objective is to test the hypothesis that a longer duration (i.e., augmented) hypoxia protocol, favoring adenosine mechanisms, enhances respiratory motor plasticity more than an AIH protocol targeting serotonin mechanisms (low O2 + CO2) in people with sub-acute SCI. Since an individual's genetics can influence the response to rehabilitation, we are also investigating how certain genes are related to breathing changes after these treatments. Data acquired through this pilot study will be used to inform a larger, more definitive clinical trial and will contribute to estimations of the magnitude and direction of effects.
Who can join: Review the eligibility criteria below.
Location: Brooks Rehabilitation โ Jacksonville, Florida
Age range: 18 Years to 70 Years
๐งช Interventions in This Study
- Augmented Acute Intermittent Hypoxia (aAIH) (OTHER)
- Acute Intermittent Hypercapnic-Hypoxia (AIHH) (OTHER)
- Sham AIH (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Brooks Rehabilitation โ Jacksonville, Florida
๐ Contact the Study Coordinator
Phone: (904) 742-2500
Email: ejfox@phhp.ufl.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injuries (SCI)
- Radio-frequency (RF) Bladder Monitor โ Montreal, Quebec
- Functional Electrical Stimulation Plus High Intensity Interval Training at Home โ Toronto, Ontario
- Comparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries โ Vancouver, British Columbia
- mSCI: Mobile Health App for Veterans With SCI and Caregivers โ Pittsburgh, Pennsylvania
- Exploring the Feasibility and Benefits of Implementing Pelvic Floor Muscle Training During Inpatient Rehabilitation for People With Spinal Cord Injury โ Vancouver, British Columbia
- Self-balancing Personal Exoskeleton for SCI โ The Bronx, New York
Explore by condition: All Spinal Cord Injuries (SCI) clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.