Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS

NCT07571733 | Not Yet Recruiting DMC

• 1 other identifier: NSI-RLS-002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Restless Leg Syndrome (RLS)

Keywords

Restless Leg Syndrome (RLS); Neurostimultor for Restless Leg Syndorme; Neurostimulator

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline of the treatment phase to the end of the 2.5 months treatment phase

Secondary Outcomes (11)

• Treatment response to SCS in %

  From baseline of the treatment phase to end of the 2.5 months treatment phase

• Change in general health quality of life

  From baseline of the treatment period to the end of the 2.5 months treatment phase

• Change in RLS-related quality of life

  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

  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

  From baseline of the treatment period to the end of the 1 month SCS stimulation during the cross-over of the treatment period

Study Arms (2)

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

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

Device: Spinal cord stimulation (SCS)

Interventions

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.

Treatment phase: SCS-stimulation

Sham stimulation DEVICE

For the Sham stimulation condition, the amplitude of the spinal cord stimulation will be set to zero.

Treatment phase: Sham-stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Clinica ARS Medica: lead

Study Sites (2)

Clinica Ars Medica

Gravesano, Canton Ticino, 6929, Switzerland

Location

Sleep Center, Neurocenter of Southern Switzerland - EOC

Lugano, Canton Ticino, 6900, Switzerland

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Eva Koetsier, PD MD PhD

CONTACT

+41 (0)91 611 64 82; eva.koetsier@hin.ch

Mauro Manconi, MD PhD

CONTACT

+41 (0)91 811 68 25; mauro.manconi@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Eva Koetsier, PhD, LL.M, Specialist in Anaesthesiology and Interventional Pain Management

Model Details: A Double-Blind Randomized Controlled Crossover Study

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 14, 2029
• Study Completion (Estimated): February 14, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CH (2)