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Could spinal cord stimulators calm restless legs? new study investigates

NCT ID NCT07179406

Knowledge-focused Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how spinal cord stimulators affect nerve signals and symptoms in people with Restless Leg Syndrome (RLS). Researchers will measure brain and nerve activity using EEG, EMG, and other tests while the stimulator is on or off. The study includes 50 participants, some with RLS, some with chronic pain, and some healthy controls. It aims to understand the body's response to stimulation, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Spinal cord stimulator (a device that sends electrical pulses to the spinal cord)
What this could lead to
If successful, this could point toward a new way to treat Restless Leg Syndrome using spinal cord stimulation.
What could go wrong
This is a small, early-stage study focused on measuring nerve activity, not on proving treatment effectiveness. The results may not lead to a new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Restless leg syndrome (RLS) Spinal cord stimulation (SCS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

More trials for these conditions

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