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;
Crossover
Spinal cord stimulation (SCS)
DeviceBurst SCS, a specific spinal cord stimulation waveform that delivers pulses in clusters separated by brief periods without stimulation, is chosen over other modalities due to its demonstrated ability to modulate both the sensory and affective components of pain and discomfort. Unlike traditional tonic stimulation, Burst SCS delivers stimulation patterns that more closely resemble natural neuronal firing, and may provide effective symptom relief without inducing paresthesia.
Sham stimulation
DeviceFor the Sham stimulation condition, the amplitude of the spinal cord stimulation will be set to zero.
RLS symptom severity
Change in RLS symptoms and severity as measured by the International RLS-Rating-scale (IRLS-RS) score. The IRLS-RS is a self-administered 10-item questionnaire to assess the severity of sleep disruption and symptoms in RLS patients. It has been validated by the International RLS Study group. Each item is scored from 4 (very severe) to 0 (none). The final score ranges between 0 and 40 and classifies RLS as mild (1-10), moderate (11-20), severe (21-30) and very severe (31-40). A negative change will indicate an improvement in IRLS-RS score and, therefore, in the severity of sleep disruption and symptoms of RLS.
Treatment response to SCS in %
The percentage of patients with prolonged response to SCS treatment. A responder is defined as a patient with ≥ 50% reduction (partial responder with ≥ 20%-49% reduction) in the IRLS-RS score.
Change in general health quality of life
Change in general health quality of life as measured by the EuroQualityOfLife-5 dimensions (EQ-5D-5L). The EQ-5D-5L questionnaire is a measure of health-related quality of life that includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five levels of problems (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme), describing 3125 separate health states. The EQ-5D-5L also includes a visual analogue scale (VAS), which records the respondent's self-rated health 'today' on a vertical, visual analogue scale, ranging from 0 "worst imaginable health state" to 100 "best imaginable health state" \[26\]. A total sum score, ranging from 5 to 25, can also be calculated from the EQ-5D-5L data by summing the levels on the five dimensions, whereby 5 represents the best health state (i.e., no problems in all five dimensions, 11111) and 25 represents the worst health state (i.e., severe problems in all five dimensions, 55555).
Change in RLS-related quality of life
Change in RLS-related quality of life as measured by the Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL). The RLSQoL is an 18-item self-reported questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life. Thirteen items are scored on a 5-point scale, the remaining are recorded as either a numerical value or a dichotomous response. Total score range from 0 to 100 with higher scores indicate a better quality of life. A positive change will indicate an improvement in RLSQoL score and, therefore, in the quality of life of RLS patients.
Change of Total Sleep Time (TST), Sleep Latency (SL) and Sleep Efficacy (SE) acquired by actigraphy
Change of Total Sleep Time (TST), Sleep Latency (SL) and Sleep Efficacy (SE) acquired by actigraphy with measurements performed prior to the start of the treatment period (from Day -7 to Day -1), in the respective second week of the two weeks of SCS stimulation during the cross-over of the treatment period. The actigraphy is a standard procedure used to measure day-night motor activity and, thus, evaluate circadian rhythms and their disturbances. A small actigraph unit in a wrist-watch-like package is worn on the wrist for a week to measure gross motor activity and, thus, sleep-wake cycles. The movements of the patients are continually recorded. The following objective actigraphy parameters will be evaluated: TST = total amount of sleep time scored during the total recording time. SL = time in minutes from lights off, that marks the patient attempts to sleep, until the first epoch scored as sleep. SE = percentage of total sleep time divided by the time spent in bed
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