Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury (NCT04458324)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Spaulding Hospital Cambridge — Cambridge, Massachusetts
Age range: 18 Years to 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Spaulding Hospital Cambridge — Cambridge, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injuries
- Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury — Montreal, Quebec
- Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity — Philadelphia, Pennsylvania
- SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI — Manhasset, New York
- Autologous Adipose Derived Mesenchymal Stem Cells for Spinal Cord Injury Patients — Rochester, Minnesota
- Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation — Louisville, Kentucky
- Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury — Cambridge, Massachusetts
Explore by condition: All Spinal Cord Injuries clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.