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.
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;
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;