NCT07179406 The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
| NCT ID | NCT07179406 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Restless Leg Syndrome (RLS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-08-04 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07179406 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Restless Leg Syndrome (RLS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07179406 currently recruiting?
Yes, NCT07179406 is actively recruiting participants. Contact the research team at mtholland@uabmc.edu for enrollment information.
Where is the NCT07179406 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT07179406 clinical trial?
NCT07179406 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 50 participants.