An interventional study of Spinal Cord Stimulation in Restless Leg Syndrome (RLS) and Spinal Cord Stimulation (SCS), sponsored by Marshall Holland. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Marshall Holland · Not applicable, Interventional, and Treatment
This prospective, single-center, first-in-indication feasibility study will evaluate the safety and preliminary effectiveness of spinal cord stimulation (SCS) for the treatment of severe, treatment-refractory primary Restless Legs Syndrome (RLS). Participants will undergo implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System and will be followed for 24 months with clinical, neurophysiological, and patient-reported outcome assessments.
Restless Legs Syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs that disrupts sleep and quality of life. Current medical therapies often lose effectiveness over time or are associated with significant side effects. Preliminary case reports suggest that spinal cord stimulation (SCS) may improve RLS symptoms.
This single-arm feasibility study will enroll up to 15 adults with severe, treatment-refractory primary RLS. Participants will undergo baseline clinical, neuropsychological, and electrophysiological assessments followed by implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System. Follow-up evaluations will occur through 24 months post-activation. Primary outcomes focus on device and procedure safety. Secondary outcomes evaluate changes in RLS severity, patient-reported outcomes, neurophysiological biomarkers, and device utilization.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
This study's planned enrollment of 15 is below the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Browse Restless Legs Syndrome studies →Marshall Holland is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Spinal Cord Stimulation
Implantation of the FDA-approved Saluda Medical Evoke® Spinal Cord Stimulation System with Smartloop® Technology. Two percutaneous epidural leads will be implanted in the thoracic spine (T7-T10 region) and programmed to provide chronic spinal cord stimulation for treatment of severe RLS symptoms.
Safety and Adverse Events
Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.
Time frame: Baseline through 24 months
Change in International Restless Legs Syndrome Scale (IRLS)
The IRLS is a validated 10-item patient-reported measure of Restless Legs Syndrome severity. Scores range from 0 to 40, with higher scores indicating worse symptom severity. A decrease in score from baseline indicates improvement.
Time frame: Baseline through 24 months
Clinician Global Impression Improvement Scale (CGI-I)
Time frame: Baseline through 24 months
Patient Global Impression of Improvement (PGI-I)
The PGI-I is a patient-reported global rating of change in symptoms and overall condition following treatment. Scores range from 1 to 7, where 1 = Very much improved and 7 = Very much worse. Lower scores represent a better outcome and greater perceived improvement.
Time frame: Baseline through 24 months
Suggested Immobilization Test (SIT)
Time frame: Baseline through 24 months
PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures
Time frame: Baseline through 24 months
Changes in Neurophysiological Measures of Spinal Cord Stimulation Response
Changes in H-reflexes, somatosensory evoked potentials (SSEPs), EEG measures, and device-recorded ECAPs.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Sleep
Questionnaire assessing perceived sleep quality and difficulty falling asleep during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater sleep disturbance and a worse outcome. The T-score range is approximately 20 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Pain
Questionnaire assessing the impact of pain on daily activities and sleep during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater pain interference and a worse outcome. The T-score range is approximately 30 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Anxiety
Questionnaire assessing fear, anxious mood, and anxiety-related symptoms during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater anxiety and a worse outcome. The T-score range is approximately 40 to 85.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Depression
Questionnaire assessing depressive symptoms, negative mood, and diminished self-worth during the previous 7 days. Responses are converted to PROMIS standardized T-scores. Higher scores indicate greater depressive symptom burden and a worse outcome. The T-score range is approximately 40 to 85.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Cognition
Questionnaire assessing perceived cognitive abilities including memory, concentration, and mental acuity. Responses are converted to PROMIS standardized T-scores . Higher scores indicate better cognitive functioning and a better outcome. The T-score range is approximately 20 to 80.
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Mental health battery
Assesses overall mental health. Responses are converted to PROMIS standardized T-scores. Higher scores indicate better overall health status and a better outcome. T-score range is approximately 20 to 80
Time frame: Baseline through 24 months
Patient-Reported Outcomes Measurement Information System - Physical Health Battery
Assesses Overall Physical Health. Responses are converted to PROMIS standardized T-scores. Higher scores indicate better overall health status and a better outcome. T-score range is approximately 20 to 80
Time frame: Baseline through 24 months
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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