Breathing high oxygen levels to improve function after spinal cord injury
Can Brief Exposure to Hyperoxia Improve Function After Chronic Spinal Cord Injury?
This study is testing if breathing in high levels of oxygen for a short time can help improve movement and feeling in people with serious spinal cord injuries.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05467215 on ClinicalTrials.gov |
What this trial studies
This proof-of-principle study investigates whether brief exposure to high concentrations of oxygen can enhance sensory and motor functions in individuals with subacute or chronic severe spinal cord injuries. Participants will undergo four experimental sessions where their reflex and sensory functions will be assessed before and after inhaling either room air or 99% oxygen for two minutes. The study aims to determine if this short exposure leads to measurable improvements in function, potentially paving the way for further therapeutic exploration. The safety of high oxygen exposure has been previously established in various injury contexts.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-65 with traumatic spinal cord injuries that occurred at least three months prior and classified as AIS A, B, or C.
Not a fit: Patients with uncontrolled autonomic dysreflexia, significant cardiovascular issues, or severe cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to new therapeutic strategies for improving function in patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown that high oxygen exposure can be safe and potentially beneficial in various injury contexts, suggesting a promising avenue for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals with traumatic SCI with onset ≥3 months prior, 2. Between 18 - 65 yr old, 3. ASIA Impairment Scale at discharge classified as A, B or C, 4. Injury level between C5 and T10, 5. Able to give informed, written consent. Exclusion Criteria: 1. Frequent uncontrolled autonomic dysreflexia, 2. Uncontrolled high blood pressure, 3. Cardiac or cardiovascular disease, 4. Cancer, 5. Active urinary tract infection, 6. Active pressure sores, 7. Signs of deep vein thrombosis in the legs, 8. Severe swelling of the feet and/or legs, 9. Severe cognitive impairment, 10. Pulmonary dysfunction such as chronic obstructive pulmonary disease or acute respiratory infection, 11. Any condition which would be exacerbated by sitting or lying in one position for 2 hours, such as low back pain 12. Pregnancy.
Where this trial is running
Edmonton, Alberta
- University of Alberta, Clinical Sciences Bldg — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Jaynie Yang — University of Alberta
- Study coordinator: Michelle Barnes, PT
- Email: carre@ualberta.ca
- Phone: 780-492-4858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.