ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury (NCT07147296)
🩺 Plain-English Summary (8th-Grade Level)
Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in individuals with chronic SCI (\>1 year after SCI). The primary effectiveness outcome will be evaluated through subject-reported ADFSCI and seated blood pressure assessments at 3 months post-implant. Following a baseline screening period and the surgical implantation of the ARC-IM System, subjects will be randomized with a 2:1 ratio into an active or control arm for 3 months. All the subjects will undergo therapy activation sessions (into either Group 1: active intervention, or Group 2: intervention aimed to mimic the active intervention without the active component) within 21 days of the surgical implant and will then commence independent at-home use of ARC-IM Therapy. At the 3 Month timepoint, after all assessments are conducted, all subjects will transition to the open-label period in order to receive the active version of the ARC-IM System in an open-label fashion. All subjects will undergo therapy programming sessions following Month 3.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for medical Sciences — Little Rock, Arkansas
Age range: 18 Years to 75 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 (13 Sites)
- University of Arkansas for medical Sciences — Little Rock, Arkansas
- Craig Hospital — Englewood, Colorado
- University of Miami — Miami, Florida
- Shepherd Center / Emory University — Atlanta, Georgia
- UofL Health - Frazier Rehabilitation Institute — Louisville, Kentucky
- VA Louisville — Louisville, Kentucky
- Kennedy krieger Institute — Baltimore, Maryland
- Spaulding Rehabilitation — Cambridge, Massachusetts
- Mayo clinic — Rochester, Minnesota
- Columbia University Irving Medical Center/ New York-Presbyterian Hospital — New York, New York
- James J. Peters VA Medical Center — The Bronx, New York
- Oregon Health & Science University — Portland, Oregon
- ICORD — Vancouver, British Columbia
📞 Contact the Study Coordinator
Phone: (501) 398-8622
Email: TRICoordinators@uams.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.