Could a spinal implant quiet severe restless legs?
NCT ID NCT07780032
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
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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
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2034
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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UAB Hospital
Birmingham, Alabama, 35233, United States
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