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The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

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

NCT07179406

University of Alabama at Birmingham

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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