Task-specific Epidural Stimulation Study (NCT03364660)
Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury
🩺 Plain-English Summary (8th-Grade Level)
The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.
Who can join: Review the eligibility criteria below.
Location: University of Louisville — Louisville, Kentucky
Age range: 18 Years
🧪 Interventions in This Study
- Acute epidural stimulation for cardiovascular stability (DEVICE)
- Long Term Epidural Stimulation for Cardiovascular Stability (DEVICE)
- Participants undergo approximately 4 months of epidural stimulation for voluntary movement. (DEVICE)
- Long Term Epidural Stimulation for Cardiovascular Stability plus Stand Training (DEVICE)
- Participants undergo approximately 4 months of epidural stimulation for voluntary movement plus stand training. (DEVICE)
📋 "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)
- University of Louisville — Louisville, Kentucky
📞 Contact the Study Coordinator
Phone: (502) 582-7443
Email: susan.harkema@louisville.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.