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Combination Therapy to Improve SCI Recovery.
Sponsor: Spaulding Rehabilitation Hospital
Summary
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.
Official title: Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery in Persons With Chronic SCI: The BO2ST Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-01-17
Completion Date
2026-12
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Daily acute intermittent hypoxia
Each participant will be exposed to 8 sessions of daily acute intermittent hypoxia via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02).
Room air (SHAM)
Each participant will be exposed to 8 sessions of daily room air via air generators over the span of two weeks. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02).
Walking + tSTIM
Individuals will participate in 45 minutes of gait training while having transcutaneous spinal cord stimulation. Stimulation intensity will be 80% involuntary motor threshold.
Walking + Sham transcutaneous spinal stimulation (tSHAM)
Individuals will participate in 45 minutes of gait training while having SHAM transcutaneous spinal cord stimulation. The stimulation will briefly increase to 80% involuntary motor threshold and then brought down to 0 within 30 seconds.
Locations (2)
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States