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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

University of Alabama at Birmingham · NCT07179406

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
1
Study start
August 4, 2025
Record last updated
June 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: H-Reflex; Somatosensory evoked potential (SSEP); Vibratory Electrophysiological Response Potential (ERP); Transcranial Magnetic Stimulation (TMS); Spinal Cord Stimulator (SCS) manipulation

Conditions: Restless Leg Syndrome (RLS); Spinal Cord Stimulation (SCS)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35233

    Site contact: Marshall Holland, MD · 2059343411 · mtholland@uabmc.edu

Study contacts (from the official record)

  • Marshall Holland, MD · 2059343411 · mtholland@uabmc.edu
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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome (NCT07179406) | Bored Studies