The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
Key facts
- Where
- Birmingham, United StatesSee the site
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesContact: Marshall Holland, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT07179406
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
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.
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: Currently using another device to treat RLS; Other medical condition that would put the subject at risk as determined by the investigator; 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; Any mental or physical limitation that would prevent completing any of the studies; Unable or unwilling to comply with study protocols; 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.