Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Se… (NCT07571733) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS
Switzerland15 participantsStarted 2026-06-01
Plain-language summary
A Double-Blind Randomized Controlled Crossover Study to compare the short-efficacy of Burst-SCS with Sham Stimulation, in patients with severe to very severe RLS refractory or intolerant to standard available treatments and/or patients in augmentation, with a two-period-alternating treatment design.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female (all sexes) aged 18 years or older, inclusive;
* Diagnosis of primary or secondary RLS;
* Severe to very severe RLS defined as IRLS-RS score \> 20;
* Duration of RSL symptoms ≥ 6 months;
* Insufficient symptom control achieved by and/or intolerance to established mono- or combination therapy of standard pharmacological treatment incl. patients in augmentation;
* Stable pharmacologic therapy for RLS for at least 1 month;
* A stable pattern of neurological symptoms;
* Patients who are legally competent and able to understand the nature, scope and aim of the clinical trial;
* Signed informed subject consent form
Exclusion Criteria:
* Known hypersensitivity or allergy to the materials of the device;
* Concomitant use of psychoactive-drugs (e.g. benzodiazepines, antidepressants; wash-out period: at least 7 days or longer depending on half-life);
* Co-morbid sleep disorders influencing sleep structure and nocturnal motor pattern (e.g. Narcolepsy, REM sleep behaviour disorder etc.);
* Coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation;
* Active infection, systemic or localized;
* Known immune deficiency;
* Presence of spinal cord or peripheral nerve stimulators;
* Any disease process or condition that may make the effect of the treatment difficult to evaluate (e.g. cancer with low life expectancy);
* Severe psychiatric disorders (including substance…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RLS symptom severity
Timeframe: From baseline of the treatment phase to the end of the 2.5 months treatment phase