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Spinal Cord Stimulators for Restless Leg Syndrome

This study is looking at how Spinal Cord Stimulators (SCS) affect people with Restless Leg Syndrome (RLS). Researchers want to understand how SCS changes the nervous system's activity. You might be able to join if you have RLS, haven't changed your RLS medications recently, and are at least 18 years old. The study will measure changes in your nervous system's responses, like H-reflex, Somatosensory Evoked Potential (SSEP), and Vibratory Electrophysiological Response Potential (ERP), up to three weeks after you join. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This interventional study plans to enroll 50 participants across four groups, including those with RLS, healthy controls, and individuals with existing or planned SCS.
What's involved
You will undergo various assessments including EEG, EMG, H-reflex, SSEP, ERP, and Transcranial Magnetic Stimulation (TMS) under different Spinal Cord Stimulator (SCS) conditions.
Compensation
Not stated in the trial record.
Follow-up
Your nervous system's responses will be measured up to three weeks after you consent to the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07179406

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Recruiting
NAAges 18+InterventionalBasic science
University of Alabama at Birmingham
~50 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:H-ReflexSomatosensory evoked potential (SSEP)Vibratory Electrophysiological Response Potential (ERP)Transcranial Magnetic Stimulation (TMS)Spinal Cord Stimulator (SCS) manipulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)
Measured over Up to 3 Weeks after consent to the study
+3 more outcomes measured

Conditions

Restless Leg Syndrome (RLS)
Spinal Cord Stimulation (SCS)

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NCT07179406

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Alabama at Birmingham

    Birmingham, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Marshall Holland, MD
[email protected]
2059343411
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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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.

What this trial measures

  • Changes in H-reflex neurophysiological activity in response to Spinal Cord Stimulation (SCS)Up to 3 Weeks after consent to the study
  • Changes in Somatosensory Evoked Potential (SSEP) activity in response to Spinal Cord Stimulation (SCS)Up to 3 Weeks after consent to the study
  • Changes in Vibratory Electrophysiological Response Potential (ERP) activity in response to Spinal Cord Stimulation (SCS)Up to 3 Weeks after consent to the study
  • Changes in Transcranial Magnetic Stimulation (TMS) activity in response to Spinal Cord Stimulation (SCS)Up to 3 Weeks after consent to the study