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RECRUITING
NCT06521723
NA

Low Oxygen Therapy to Enhance Walking Recovery After SCI.

Sponsor: Spaulding Rehabilitation Hospital

View on ClinicalTrials.gov

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 of different age groups.

Official title: Breathing Low Oxygen to Enhance Spinal Stimulation Training and Functional Recovery for Aging Adults With Chronic SCI: The BO2ST-II Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-06

Completion Date

2028-09-30

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

OTHER

Daily acute intermittent hypoxia

Each participant will be exposed to 16 sessions of daily acute intermittent hypoxia via air generators over the span of four 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).

DEVICE

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.

Locations (2)

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, United States