Clinical Research Directory

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 abuse, major depression, and similar severe disorders known or suspected non-compliance) which could have a negative influence on successful treatment; * Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant; * Women who are pregnant or breast feeding; * Intention to become pregnant during the course of the study;