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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT04458324

Run by

Spaulding Rehabilitation Hospital

People needed

70

Starts

2020-12-22

Expected to finish

2027-07-31

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SCI outpatients aged 18-55 years
• medically stable
• body mass index 18.5-30 kg/m2 to include normal to overweight but not obese individuals
• 3-months to 6-years post-injury
• ASIA Scale A, B, or C injury at or above neurological level T4
• able to follow directions
• wheelchair users
• leg muscles responsive to stimulation

You may not qualify if…

• BP >140/90 mmHg to exclude for hypertension (though rare in those with high level SCI)
• current tobacco users
• significant arrhythmias
• coronary disease
• diabetes
• renal disease
• cancer
• epilepsy
• current use of cardioactive medications (except medication to support blood pressure)
• current grade 2 or greater pressure ulcers at relevant contact sites
• other neurological disease
• peripheral nerve compressions or rotator cuff tears that limit the ability to row
• history of bleeding disorders
• current use of buspirone
• pregnancy
• contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)

Where it is running

• Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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