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RECRUITING
NCT05563103
NA

Combination Therapy to Improve SCI Recovery.

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.

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

Interventions

OTHER

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).

OTHER

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).

OTHER

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.

OTHER

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