Breathing low oxygen to improve movement after spinal injury
Mechanisms of Intermittent Hypoxia-induced Motor Recovery in Persons With SCI
This study is testing if breathing low oxygen for short periods can help people with chronic spinal cord injuries improve their movement and walking ability when combined with exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT02323945 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of breathing low oxygen levels in brief bouts, known as intermittent hypoxia, on improving motor function and spinal plasticity in individuals with chronic spinal cord injuries. The research aims to understand how this treatment can enhance walking ability and muscle coordination, particularly when combined with walking or strength training. Participants will undergo a series of interventions to assess the impact of intermittent hypoxia on their mobility and strength over a defined period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with motor-incomplete spinal cord injuries that are stable and have visible leg movement.
Not a fit: Patients with severe concurrent medical conditions, pregnant women, or those with a history of seizures or brain injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant improvements in mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with intermittent hypoxia in enhancing motor function in spinal cord injury patients, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 and 75 years (the latter to reduce likelihood of heart disease) * Medical clearance to participate * Lesion at or below C2 and above T12 with non-progressive etiology * Classified as motor-incomplete with visible volitional leg movement * Injury greater than 1 year Exclusion Criteria: * Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications) * Pregnant women because of the unknown affects of AIH on pregnant women and fetus * History of seizures, brain injury, and/or epilepsy * Undergoing concurrent physical therapy * Diabetes * Cirrhosis * Caffeine and/or NSAID allergies or intolerances
Where this trial is running
Cambridge, Massachusetts
- Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Randy D Trumbower, PT, PhD — Harvard Medical School (HMS and HSDM)
- Study coordinator: Randy D Trumbower, PT, PhD
- Email: randy.trumbower@mgh.harvard.edu
- Phone: 617-952-6951
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.