Restless Leg Syndrome (RLS)REST-SCSNCT07571733
Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS
A study testing Spinal cord stimulation (SCS) in people with Restless Leg Syndrome (RLS), run by Clinica ARS Medica at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Leg Syndrome (RLS)
- What is being tested?
- Spinal cord stimulation (SCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jun 2026to 14 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
Clinica Ars Medica
Gravesano, Canton Ticino, 6929
Eva Koetsier, MD PhD, +41 (0)91 611 64 82, eva.koetsier@hin.ch
Sleep Center, Neurocenter of Southern Switzerland - EOC
Lugano, Canton Ticino, 6900
Mauro Manconi, MD PhD, +41 (0)91 811 68 25, mauro.manconi@eoc.ch
Sandra Hackethal, MD
About this study
Official title: A Double-Blind, Randomized, Sham-Controlled, Crossover Study on the Efficacy of Burst Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS: the REST-SCS Study
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.
Read the detailed description
Restless Legs Syndrome (RLS) is a common chronic sleep disorder characterized by an irresistible urge to move the legs, often accompanied by unpleasant sensations that worsens during rest, particularly at night, and improves with movement. Affecting around 5% of the population, moderate to severe RLS can lead to insomnia, involuntary leg movements during sleep (PLMS), depression, and increased cardiovascular risk, significantly impacting sleep and quality of life and typically requiring long-term treatment.
While the exact cause of RLS is unknown, genetic factors, dopamine system alterations, iron deficiency in the brain, and opioid pathways are suspected contributors. It's mainly classified as primary (unknown cause), with secondary RLS linked to other conditions.
Current first-line treatments involve dopamine agonists (DAs) and alpha-2-delta ligands, which are generally effective but can have long-term limitations. A major issue with DAs is "augmentation," a worsening of RLS symptoms that often leads to treatment discontinuation. DAs are also less effective for insomnia, often requiring combination with sedatives. Opioids are effective but are second-line due to side effects and addiction risk. Importantly, while DAs help with sensory symptoms, they often don't significantly improve sleep quality.
Emerging as a promising non-pharmacological approach is electrical neuromodulation, particularly spinal cord stimulation (SCS). Case studies have shown that SCS can improve RLS symptoms, reduce PLMS, and enhance sleep quality, although long-term efficacy has been variable. The potential mechanism of SCS involves activating sensory fibers and inhibitory interneurons in the spinal cord, influencing pain pathways, and modulating brain regions involved in motor control and sleep regulation. This multilevel action may explain the potential benefits of SCS across the sensory, sleep, and motor aspects of RLS.
SCS, typically used for chronic intractable pain, is being investigated as a potential treatment for severe RLS due to overlapping characteristics between the two conditions. RLS has a sensory component that can include pain, and there's evidence suggesting a link between RLS and chronic pain based on high comorbidity, similar sensory processing abnormalities, the effectiveness of certain medications (opioids and α2δ ligands), and a shared hyperexcitable state in the central nervous system. Notably, some patients receiving SCS for chronic pain have also experienced improvement in their RLS symptoms.
This double-blind randomized controlled crossover study aims at comparing the short-efficacy of SCS with Sham Stimulation, in patients with primary or secondary intractable severe or very severe RLS, with a two-period-alternating treatment design. Burst 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. Although specific evidence for RLS is still limited, Burst SCS has shown promising results in related neuropathic conditions and is currently considered one of the most advanced and effective neuromodulation techniques available.
- Conditions
- Restless Leg Syndrome (RLS)
- Being tested
- Spinal cord stimulation (SCS), Sham stimulation
- Keywords
- Restless Leg Syndrome (RLS), Neurostimultor for Restless Leg Syndorme, Neurostimulator
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulation (SCS)Device
Burst 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 stimulationDevice
For the Sham stimulation condition, the amplitude of the spinal cord stimulation will be set to zero.
| Study group | Role | What they receive |
|---|---|---|
| Treatment phase: Sham-stimulation | Placebo comparator | After IPG implantation Burst-SCS is turned on in all participants for 2.5. Then, they will again be double-blind randomized to the 2 treatment orders for 2 weeks per stimulation mode (Sham stimulation or SCS) as fcollows:
* Double-blind randomization to the following alternating treatment modes:
* 14 days Sham-stimulation + 14 days SCS
* 14 days SCS + 14r days Sham-stimulation Receives: Device: Sham stimulation |
| Treatment phase: SCS-stimulation | Active comparator | After IPG implantation Burst-SCS is turned on in all participants for 2.5. Then, they will again be double-blind randomized to the 2 treatment orders for 2 weeks per stimulation mode (Sham stimulation or SCS) as fcollows:
* Double-blind randomization to the following alternating treatment modes:
* 14 days Sham-stimulation + 14 days SCS
* 14 days SCS + 14r days Sham-stimulation Receives: Device: Spinal cord stimulation (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline of the treatment phase to the end of the 2.5 months treatment phase
Secondary outcomes (11)
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.
Measured: From baseline of the treatment phase to end of the 2.5 months treatment phase
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).
Measured: From baseline of the treatment period to the end of the 2.5 months treatment phase
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.
Measured: From baseline of the treatment period to the end of the 2.5 months treatment phase
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
Measured: From baseline of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period
Change of PLMS Index recorded by PSG
Change in Periodic limb movements of sleep (PLMS) index from baseline to end of either of the 1 month of stimulation cross-over measured by means of polysomnography recording. The PLMS index is defined as number of PLMS per hour of sleep / total PSG sleep time in minutes.
Measured: From baseline of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period
Difference in RLS symptoms and severity between 1 month of SCS vs. Sham stimulation
Difference in RLS symptoms and severity between 1 month of SCS vs. Sham stimulation measured by the 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.
Measured: Between 1 month of SCS vs. Sham stimulation
Difference in health-related quality of life between 1 month of SCS vs. Sham stimulation
Difference in health-related quality of life between 1 month of SCS vs. Sham stimulation measured by the 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". 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 and 25 represents the worst health state.
Measured: Between 1 month of SCS vs. Sham stimulation
Difference in RLS-related quality of life between 1 month of SCS vs. Sham stimulation
Difference in RLS-related quality of life between 1 month of SCS vs. Sham stimulation measured by the RLSQoL score. The RLSQoL [23, 24] 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.
Measured: Between 1 month of SCS vs. Sham stimulation
Difference between 1 month of SCS vs. Sham stimulation in TST, SL and SE
Difference between 1month of SCS vs. Sham stimulation in TST, SL and SE acquired by actigraphy. 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
Measured: Between 1 month of SCS vs. Sham stimulation
Change of sleep parameters recorded by PSG
Change in PSG-related sleep parameters (Total Sleep Time, Sleep Latency, Sleep Efficacy, Number of awakenings, Arousal index) from baseline to end of either of the 1 month of stimulation cross-over measured by means of polysomnography recording. The following PSG-related sleep parameters will be measured: Total Sleep Time (total amount of sleep time scored during the total recording time); Sleep Latency (time in minutes from lights off, that marks the patient attempts to sleep, until the first epoch scored as sleep); Sleep Efficacy (percentage of total sleep time divided by the time spent in bed); Number of awakenings (the total number of awakenings during the total sleep time); Arousal index (the number of arousals per hour of sleep).
Measured: From baselene of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period.
Difference between one month of SCS vs. Sham stimulation in PLMS index, TST, SL, SE, number of awakenings and arousal index
Difference between 1 month of SCS vs. Sham stimulation in PLMS index, TST, SL, SE, number of awakenings and arousal index recorded by PSG. PSG recordings will be carried out in standard sound-attenuated sleep laboratory rooms. The PSG recording may also be performed at home. However, the preparation for the procedure should be carried out at the hospital. Recordings will include electroencephalogram (EEG) (F3, F4, C3, C4, O1, O2 referenced to contralateral mastoid), electroculogram (EOG), electromyogram (EMG) of the submentalis muscle, and EMG of the right and left tibialis anterior muscles. In addition, ECG (CM4 derivation) and sleep respiratory pattern (nasal air flow, thoracic and abdominal respiratory effort, oxygen saturation) will be monitored. Sleep parameters, leg movements, and arousals will be scored according to standardized guidelines. All sleep signals will be stored on hard disk for further analysis.
Measured: Between 1 month of SCS vs. Sham stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion14 Feb 2029 (estimated)
- Study completion14 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Double-Blind Randomized Controlled Crossover Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica ARS Medica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Koetsier, Clinica ARS Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571733
- Sponsor's protocol ID
- NSI-RLS-002
- Acronym
- REST-SCS
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared upon resonable request by qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Sham-Controlled, Crossover Study on the Efficacy of Burst Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS: the REST-SCS Study
- ClinicalTrials.gov ID
- NCT07571733
- Acronym / sponsor ID
- REST-SCS / NSI-RLS-002
- Conditions
- Restless Leg Syndrome (RLS)
- Keywords
- Restless Leg Syndrome (RLS), Neurostimultor for Restless Leg Syndorme, Neurostimulator
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Clinica ARS MedicaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 14 Feb 2029 (estimated)
- Study completion
- 14 Feb 2029 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Restless Legs Syndrome (RLS) is a common chronic sleep disorder characterized by an irresistible urge to move the legs, often accompanied by unpleasant sensations that worsens during rest, particularly at night, and improves with movement. Affecting around 5% of the population, moderate to severe RLS can lead to insomnia, involuntary leg movements during sleep (PLMS), depression, and increased cardiovascular risk, significantly impacting sleep and quality of life and typically requiring long-term treatment.
While the exact cause of RLS is unknown, genetic factors, dopamine system alterations, iron deficiency in the brain, and opioid pathways are suspected contributors. It's mainly classified as primary (unknown cause), with secondary RLS linked to other conditions.
Current first-line treatments involve dopamine agonists (DAs) and alpha-2-delta ligands, which are generally effective but can have long-term limitations. A major issue with DAs is "augmentation," a worsening of RLS symptoms that often leads to treatment discontinuation. DAs are also less effective for insomnia, often requiring combination with sedatives. Opioids are effective but are second-line due to side effects and addiction risk. Importantly, while DAs help with sensory symptoms, they often don't significantly improve sleep quality.
Emerging as a promising non-pharmacological approach is electrical neuromodulation, particularly spinal cord stimulation (SCS). Case studies have shown that SCS can improve RLS symptoms, reduce PLMS, and enhance sleep quality, although long-term efficacy has been variable. The potential mechanism of SCS involves activating sensory fibers and inhibitory interneurons in the spinal cord, influencing pain pathways, and modulating brain regions involved in motor control and sleep regulation. This multilevel action may explain the potential benefits of SCS across the sensory, sleep, and motor aspects of RLS.
SCS, typically used for chronic intractable pain, is being investigated as a potential treatment for severe RLS due to overlapping characteristics between the two conditions. RLS has a sensory component that can include pain, and there's evidence suggesting a link between RLS and chronic pain based on high comorbidity, similar sensory processing abnormalities, the effectiveness of certain medications (opioids and α2δ ligands), and a shared hyperexcitable state in the central nervous system. Notably, some patients receiving SCS for chronic pain have also experienced improvement in their RLS symptoms.
This double-blind randomized controlled crossover study aims at comparing the short-efficacy of SCS with Sham Stimulation, in patients with primary or secondary intractable severe or very severe RLS, with a two-period-alternating treatment design. Burst 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. Although specific evidence for RLS is still limited, Burst SCS has shown promising results in related neuropathic conditions and is currently considered one of the most advanced and effective neuromodulation techniques available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-Blind Randomized Controlled Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Treatment phase: Sham-stimulation | Placebo comparator | Device: Sham stimulationAfter IPG implantation Burst-SCS is turned on in all participants for 2.5. Then, they will again be double-blind randomized to the 2 treatment orders for 2 weeks per stimulation mode (Sham stimulation or SCS) as fcollows: * Double-blind randomization to the following alternating treatment modes: * 14 days Sham-stimulation + 14 days SCS * 14 days SCS + 14r days Sham-stimulation |
| Treatment phase: SCS-stimulation | Active comparator | Device: Spinal cord stimulation (SCS)After IPG implantation Burst-SCS is turned on in all participants for 2.5. Then, they will again be double-blind randomized to the 2 treatment orders for 2 weeks per stimulation mode (Sham stimulation or SCS) as fcollows: * Double-blind randomization to the following alternating treatment modes: * 14 days Sham-stimulation + 14 days SCS * 14 days SCS + 14r days Sham-stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulation (SCS)Burst 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. | Device | Treatment phase: SCS-stimulation |
| Sham stimulationFor the Sham stimulation condition, the amplitude of the spinal cord stimulation will be set to zero. | Device | Treatment phase: Sham-stimulation |
Primary outcome
RLS symptom severity
Time frame: From baseline of the treatment phase to the end of the 2.5 months treatment phase
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.
11 secondary outcomes
Treatment response to SCS in %
Time frame: From baseline of the treatment phase to end of the 2.5 months treatment phase
Change in general health quality of life
Time frame: From baseline of the treatment period to the end of the 2.5 months treatment phase
Change in RLS-related quality of life
Time frame: From baseline of the treatment period to the end of the 2.5 months treatment phase
Change of Total Sleep Time (TST), Sleep Latency (SL) and Sleep Efficacy (SE) acquired by actigraphy
Time frame: From baseline of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period
Change of PLMS Index recorded by PSG
Time frame: From baseline of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period
Difference in RLS symptoms and severity between 1 month of SCS vs. Sham stimulation
Time frame: Between 1 month of SCS vs. Sham stimulation
Difference in health-related quality of life between 1 month of SCS vs. Sham stimulation
Time frame: Between 1 month of SCS vs. Sham stimulation
Difference in RLS-related quality of life between 1 month of SCS vs. Sham stimulation
Time frame: Between 1 month of SCS vs. Sham stimulation
Difference between 1 month of SCS vs. Sham stimulation in TST, SL and SE
Time frame: Between 1 month of SCS vs. Sham stimulation
Change of sleep parameters recorded by PSG
Time frame: From baselene of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period.
Difference between one month of SCS vs. Sham stimulation in PLMS index, TST, SL, SE, number of awakenings and arousal index
Time frame: Between 1 month of SCS vs. Sham stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon resonable request by qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation (SCS) in people with Restless Leg Syndrome (RLS), run by Clinica ARS Medica at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Koetsier, PD MD PhD (+41 (0)91 611 64 82, eva.koetsier@hin.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RLS symptom severity (time frame: From baseline of the treatment phase to the end of the 2.5 months treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.