๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-18

Neuromodulation to Overcome Severe Restless Legs Syndrome (NCT07780032)

Neuromodulation to Overcome Severe Restless Legs Syndrome (NO RLS)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Marshall Holland

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This prospective, single-center, first-in-indication feasibility study will evaluate the safety and preliminary effectiveness of spinal cord stimulation (SCS) for the treatment of severe, treatment-refractory primary Restless Legs Syndrome (RLS). Participants will undergo implantation of the Saluda Medical Evokeยฎ Spinal Cord Stimulation System and will be followed for 24 months with clinical, neurophysiological, and patient-reported outcome assessments.

Who can join: Review the eligibility criteria below.

Location: UAB Hospital โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • UAB Hospital โ€” Birmingham, Alabama

๐Ÿ“ž Contact the Study Coordinator

Phone: (205) 996-4318

Email: clgonzalez@uabmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—