Spinal cord stimulator effects on restless legs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Study coordinator: Marshall Holland, MD
• Email: mtholland@uabmc.edu
• Phone: 2059343411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.