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Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery for Aging Adults With Chronic SCI: The BO2ST-II 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 of different age groups.
The goal of the study is to determine the optimal dosage for different age groups of repeatedly breathing mild bouts of low oxygen for brief periods (termed acute intermittent hypoxia (AIH)) combined with transcutaneous spinal cord stimulation (tSTIM) to improve recovery of walking and strength after spinal cord injury. Preliminary studies have shown that combining AIH and tSTIM with walking training can enhance individuals walking training greater than just AIH or tSTIM. By using low oxygen as a pre-treatment to tSTIM during walking training, functional independence and quality of life may improve. Despite exciting preliminary results supporting the efficacy of AIH and tSTIM to enhance walking recovery after SCI, understanding factors that may enhance or undermine treatment responsiveness is warranted. Factors include establishing the role of age and sex dependency on appropriate dosing (number of sessions) AIH to provide the greatest plasticity-promoting effects on walking recovery for our aging population of persons living with SCI.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Brooks Rehabilitation Hospital
Jacksonville, Florida, United States
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States
Start Date
June 6, 2025
Primary Completion Date
September 30, 2027
Completion Date
September 30, 2028
Last Updated
March 20, 2026
60
ESTIMATED participants
Daily acute intermittent hypoxia
OTHER
Walking + tSTIM
DEVICE
Lead Sponsor
Spaulding Rehabilitation Hospital
Collaborators
NCT05563103
NCT07386522
NCT07210411
Data Source & Attribution
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