Combination Therapy for Spinal Cord Injury
(BO2ST Trial)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine how combining bouts of low oxygen, transcutaneous spinal cord stimulation, and walking training may improve walking function for people with chronic spinal cord injury.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, if you have an active implanted device or are receiving electrical stimulation, you may not be eligible to participate.
What data supports the effectiveness of the treatment Combination Therapy for Spinal Cord Injury?
Research shows that brief episodes of low oxygen breathing, known as acute intermittent hypoxia (AIH), can enhance walking recovery in people with spinal cord injuries by promoting changes in the spinal cord that improve walking speed and endurance. Combining AIH with walking therapy and transcutaneous spinal stimulation (tSTIM) may lead to faster and more lasting improvements in walking ability.12345
Is the combination therapy for spinal cord injury safe for humans?
The combination therapy involving intermittent hypoxia and walking training has been studied in humans with spinal cord injuries, and safety measures such as monitoring pain, spasticity, sleep behavior, cognition, and blood pressure were included in the trials. Repetitive intermittent hypoxia is considered a potentially safe therapeutic alternative for improving walking function in individuals with incomplete spinal cord injuries.13467
How is the treatment for spinal cord injury using daily acute intermittent hypoxia and walking with tSTIM different from other treatments?
This treatment is unique because it combines brief episodes of low-oxygen breathing (acute intermittent hypoxia) with transcutaneous spinal stimulation and walking training to enhance walking recovery in people with spinal cord injuries. This combination aims to promote neuroplasticity (the brain's ability to reorganize itself) and improve walking function more effectively than either treatment alone.12345
Eligibility Criteria
This trial is for adults aged 18-70 with chronic spinal cord injury (SCI) that's non-progressive and occurred over a year ago. Participants must be able to walk 10 meters without help, have some preserved sensory or motor function below the injury level, and score C-D on the ASIA scale. Pregnant individuals, those with active implants like baclofen pumps, recent botulinum toxin injections in legs, severe concurrent illnesses or certain surgeries are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a combination of acute intermittent hypoxia, transcutaneous spinal cord stimulation, and walking training to improve walking function
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Daily acute intermittent hypoxia (Other)
- Room air (SHAM) (Other)
- Walking + Sham transcutaneous spinal stimulation (tSHAM) (Other)
- Walking + tSTIM (Other)
Daily acute intermittent hypoxia is already approved in United States for the following indications:
- Spinal Cord Injury Recovery
- Respiratory Function Improvement
- Walking Function Enhancement