Combining low oxygen therapy and spinal stimulation to improve walking after spinal cord injury
Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial
This study is testing if combining low oxygen therapy with spinal stimulation and walking training can help people with chronic spinal cord injuries walk better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05563103 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of combining acute intermittent hypoxia (AIH) with transcutaneous spinal cord stimulation (tSTIM) and walking training to enhance recovery of walking function in individuals with chronic spinal cord injuries. Participants will undergo daily sessions of AIH, alongside walking training with either tSTIM or a sham treatment. The approach is based on previous animal studies that suggest AIH can promote neural plasticity and improve spinal cord function. The ultimate goal is to determine if this combination leads to greater improvements in walking ability compared to using AIH or tSTIM alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic spinal cord injuries at or below C2 and at or above L2, who have some preserved sensory or motor function.
Not a fit: Patients with severe concurrent illnesses, significant pain, or those who do not meet the neurological criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking ability and quality of life for individuals with spinal cord injuries.
How similar studies have performed: Previous studies have shown promising results with similar approaches involving spinal cord stimulation and hypoxia, indicating potential for success in this novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 70 years of age * medically stable with medical clearance from study physician to participate * SCI at or below C2 (phrenic sparing) and at or above L2 with at least some sensory or motor function preserved below the neurologic level * non-progressive etiology of spinal injury * American Spinal Injury Association (ASIA) scores of C-D at initial screen * ambulatory (able to complete the 10-meter walk test without support from another person) * chronic injury (define as \> 12 months post-injury) to avoid potential for spontaneous neurological plasticity and recovery Exclusion Criteria: * severe concurrent illness or pain, including unhealed decubiti, severe neuropathic or chronic pain syndrome, severe infection (e.g., urinary tract), hypertension, cardiovascular disease, pulmonary disease, severe osteoporosis, active heterotopic ossification in the lower extremities, severe systemic inflammation * \< 24 on Mini-Mental Exam * severe recurrent autonomic dysreflexia * history of severe cardiovascular/pulmonary complications including hypertension (systolic blood pressure \> 150 mmHg) * pregnancy because of unknown effects of AIH or tSTIM on a fetus (individuals of childbearing potential will not otherwise be excluded) * botulinum toxin injections in lower extremity muscles within the prior three months * history of tendon or nerve transfer surgery in the lower extremity * untreated severe sleep-disordered breathing characterized by uncontrolled hypoxia and sleep fractionation that may impact the outcome of this study. * active implanted devices (e.g., intrathecal baclofen pump) * receiving concurrent electrical stimulation * motor threshold evoked by transcutaneous spinal stimulation \>200 mA
Where this trial is running
Chicago, Illinois and 1 other locations
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
- Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Randy Trumbower, PT, PhD — Harvard Medical School (HMS and HSDM)
- Study coordinator: Noah Piazza, BS
- Email: npiazza2@mgb.org
- Phone: 617-952-6953
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.