NCT02323945 Effects of Breathing Mild Bouts of Low Oxygen on Limb Mobility After Spinal Injury
| NCT ID | NCT02323945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2014-10 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2014-10 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.
Eligibility 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
Contact & Investigator
Randy D Trumbower, PT, PhD
PRINCIPAL INVESTIGATOR
Harvard Medical School (HMS and HSDM)
Frequently Asked Questions
Who can join the NCT02323945 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02323945 currently recruiting?
Yes, NCT02323945 is actively recruiting participants. Contact the research team at randy.trumbower@mgh.harvard.edu for enrollment information.
Where is the NCT02323945 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT02323945 clinical trial?
NCT02323945 is sponsored by Spaulding Rehabilitation Hospital. The principal investigator is Randy D Trumbower, PT, PhD at Harvard Medical School (HMS and HSDM). The trial plans to enroll 44 participants.