Neuromodulation to Overcome Severe Restless Legs Syndrome

NCT07780032 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: IRB-3000134641UG3NS145980-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Restless Leg Syndrome (RLS); Spinal Cord Stimulation (SCS)

Keywords

RLS; SCS

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events

  Frequency, severity, and relationship of device-, stimulation-, and procedure-related adverse events.

  Baseline through 24 months

Secondary Outcomes (13)

• Change in International Restless Legs Syndrome Scale (IRLS)

  Baseline through 24 months

• Clinician Global Impression Improvement Scale (CGI-I)

  Baseline through 24 months

• Patient Global Impression of Improvement (PGI-I)

  Baseline through 24 months

• Suggested Immobilization Test (SIT)

  Baseline through 24 months

• PROMIS Sleep, Pain, Anxiety, Depression, Cognition, and Health Measures

  Baseline through 24 months

Study Arms (1)

SCS Implant

EXPERIMENTAL

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

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.

SCS Implant

Eligibility Criteria

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

You may qualify if:

• Age \>18 years and older.
• Received a medical diagnosis of RLS via first screening with Cambridge Hopkins- RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire.
• IRLS Scale score ≥ 21 (classified as severe) and received a determination of treatment refractory RLS or inadequate response to standard medical treatment for RLS by a sleep medicine physician.
• RLS symptoms occur ≥ 3 nights per week.
• Willing and able to comply with study procedures.
• Able to provide informed consent.

You may not qualify if:

• Age \<18 years.
• Neuropathic pain, other than RLS on DN4 questionnaire.
• Any mental or physical limitation that would prevent completing and of the study protocols.
• Active medical implant in the body (i.e., pacemaker).
• History of prior SCS trial or implantation.
• Currently using another device to treat RLS.
• Unable or unwilling to comply with study protocols.
• Other medical conditions that would put the subject at risk as determined by the investigators.
• Pregnant, breastfeeding, or trying to become pregnant.
• Currently participating or plans to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigators, affect RLS.
• Ferritin \< 50 ng/mL (excludes iron deficiency).
• HgA1C \> 7.5 (excludes unstable diabetes melilitus)
• One or more of the following diagnoses: spinal cord injury or prior spinal surgery, severe peripheral neuropathy, severe psychiatric or cognitive disorder that may interfere with study participation, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e., Parkinson's disease), deep vein thrombosis, multiple sclerosis, known or suspected allergy to SCS materials.

Sponsors & Collaborators

• Marshall Holland: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

UAB Hospital

Birmingham, Alabama, 35233, United States

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

Study Officials

• Marshall Holland, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Gonzalez

CONTACT

2059964318; clgonzalez@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurosurgery

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2034
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)