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

Summary

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity.

This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports.

In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.

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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-22

Primary Completion

2026-07-31

Completion

2027-07-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations