๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-23

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome (NCT07179406)

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: University of Alabama at Birmingham

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

This study aims to evaluate neurophysiological responses and symptom changes in individuals with Restless Legs Syndrome (RLS) and/or chronic pain. Participants will undergo standard clinical assessments including EEG, EMG, h-reflex, SSEP, ERP, and TMS under varying SCS conditions.The study involves 4 arms. Arm 1 are individuals diagnosed with RLS and Healthy Controls. Arm 2 are individuals diagnosed with RLS and have an existing SCS. Arm 3 are individuals diagnosed with RLS and scheduled to receive a SCS. Arm 4 are individuals with chronic pain and have a SCS, but no diagnosis of RLS.

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • H-Reflex (OTHER)
  • Somatosensory evoked potential (SSEP) (OTHER)
  • Vibratory Electrophysiological Response Potential (ERP) (OTHER)
  • Transcranial Magnetic Stimulation (TMS) (OTHER)
  • Spinal Cord Stimulator (SCS) manipulation (OTHER)

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)

  • University of Alabama at Birmingham โ€” Birmingham, Alabama

๐Ÿ“ž Contact the Study Coordinator

Phone: (205) 934-3411

Email: mtholland@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†—