Status:

RECRUITING

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Restless Leg Syndrome (RLS)

Spinal Cord Stimulation (SCS)

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 assessmen...

Eligibility Criteria

Inclusion

  • Has Restless Leg Syndrome
  • No major changes in RLS medications in past 4 weeks
  • Willing and able to comply with study protocol
  • Healthy Controls - No RLS diagnosis
  • Ability to provide informed consent

Exclusion

  • Any mental or physical limitation that would prevent completing any of the studies
  • Currently using another device to treat RLS
  • Unable or unwilling to comply with study protocols
  • Other medical condition that would put the subject at risk as determined by the investigator
  • Pregnant, breastfeeding, or trying to become pregnant
  • Currently participating or planning to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigator, affect RLS
  • One or more of the following diseases: spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorder that may interfere with participation of the study, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than the common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e. Parkinson's disease), deep vein thrombosis, or multiple sclerosis.

Key Trial Info

Start Date :

January 31 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07179406

Start Date

January 31 2026

End Date

December 31 2027

Last Update

September 17 2025

Active Locations (1)

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1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233