Spinal cord stimulator effects on restless legs
The Effect of Spinal Cord Stimulators on Restless Leg Syndrome
This study will test whether changing spinal cord stimulator settings alters nerve signals and improves symptoms in people with restless leg syndrome and in some people with chronic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07179406 on ClinicalTrials.gov |
What this trial studies
This single-center interventional study at the University of Alabama at Birmingham will enroll people with RLS across four groups: RLS patients without stimulators (and healthy controls), RLS patients with existing spinal cord stimulators (SCS), RLS patients scheduled to receive an SCS, and chronic pain patients with SCS but no RLS diagnosis. Participants undergo neurophysiological testing including EEG, EMG, H-reflex, somatosensory evoked potentials (SSEP), event-related potentials (ERP), and transcranial magnetic stimulation (TMS) while SCS settings are varied. The protocol compares baseline and SCS-modulated measures to document changes in nervous-system signals and related symptom reports. Data aim to link objective electrophysiology with any symptom changes across groups.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with restless leg syndrome who can attend UAB visits, have had no major changes in RLS medications for at least four weeks, and can provide informed consent; healthy controls and chronic pain patients with SCS are included in specific arms.
Not a fit: People without RLS or those with major exclusions such as spinal cord injury, severe peripheral neuropathy or radiculopathy, severe psychiatric or cognitive disorders, current use of another RLS device, pregnancy, or inability to comply with study visits are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, the study could identify SCS settings that reduce RLS symptoms and support broader use of spinal cord stimulation as a treatment option for some patients.
How similar studies have performed: Small studies and case reports have suggested SCS can help RLS symptoms in some patients, but robust controlled data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Marshall Holland, MD
- Email: mtholloand@uabmc.edu
- Phone: 2059343411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.