Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury

PHASE2RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 22, 2020

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2026

Conditions
Spinal Cord Injuries
Interventions
DRUG

Buspirone Hydrochloride

Subjects take 30 mg buspirone HCl twice a day for 6 months.

DRUG

Buspirone placebo

Subjects take a placebo tablet twice a day for 6 months.

DEVICE

Noninvasive Ventilation (NIV)

The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

DEVICE

Sham Non-invasive ventilation (NIV)

The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.

OTHER

Functional Electrical Stimulation Row Training (FESRT)

Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.

Trial Locations (1)

02138

RECRUITING

Spaulding Hospital Cambridge, Cambridge

All Listed Sponsors
lead

Spaulding Rehabilitation Hospital

OTHER