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