Combination Therapy to Improve SCI Recovery.

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 17, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

December 31, 2026

Conditions
Spinal Cord Injuries
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.

Trial Locations (2)

60611

RECRUITING

Shirley Ryan AbilityLab, Chicago

02138

RECRUITING

Spaulding Rehabilitation Hospital, Cambridge

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Shirley Ryan AbilityLab

OTHER

lead

Spaulding Rehabilitation Hospital

OTHER