Could a spinal implant quiet severe restless legs?

NCT ID NCT07780032

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether spinal cord stimulation—a device implanted near the spinal cord that sends mild electrical pulses—can ease severe restless legs syndrome (RLS) in people who haven't improved with standard treatments. About 15 adults with severe, treatment-resistant RLS will receive the implant and be followed for 24 months. The trial focuses on safety and whether symptoms improve, using patient-reported scales and other measures.

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 stimulation using the Saluda Medical Evoke® system, an implanted device that delivers electrical pulses to the spinal cord.
What this could lead to
If it works, this could offer a new treatment option for people with severe restless legs syndrome who don't get relief from medication.
What could go wrong
This is a very small, early feasibility study, so results may not apply broadly. The procedure involves implanting a device, which carries risks like infection or device-related complications.

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 15 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2034

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Age \>18 years and older. 2. Received a medical diagnosis of RLS via first screening with Cambridge Hopkins- RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire. 3. IRLS Scale score ≥ 21 (classified as severe) and received a determination of treatment refractory RLS or inadequate response to standard medical treatment for RLS by a sleep medicine physician. 4. RLS symptoms occur ≥ 3 nights per week. 5. Willing and able to comply with study procedures. 6. Able to provide informed consent. Exclusion Criteria: 1. Age \<18 years. 2. Neuropathic pain, other than RLS on DN4 questionnaire. 3. Any mental or physical limitation that would prevent completing and of the study protocols. 4. Active medical implant in the body (i.e., pacemaker). 5. History of prior SCS trial or implantation. 6. Currently using another device to treat RLS. 7. Unable or unwilling to comply with study protocols. 8. Other medical conditions that would put the subject at risk as determined by the investigators. 9. Pregnant, breastfeeding, or trying to become pregnant. 10. Currently participating or plans to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigators, affect RLS. 11. Ferritin \< 50 ng/mL (excludes iron deficiency). 12. HgA1C \> 7.5 (excludes unstable diabetes melilitus) 13. One or more of the following diagnoses: spinal cord injury or prior spinal surgery, severe peripheral neuropathy, severe psychiatric or cognitive disorder that may interfere with study participation, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than 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, multiple sclerosis, known or suspected allergy to SCS materials.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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Contacts and locations

Locations

  • UAB Hospital

    Birmingham, Alabama, 35233, United States

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