The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07179406

Run by

University of Alabama at Birmingham

People needed

50

Starts

2025-08-04

Expected to finish

2028-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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