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Spinal Cord Stimulation for Restless Legs Syndrome

(NO RLS Trial)

CG
Overseen ByChris Gonzalez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Marshall Holland
Disqualifiers: Neuropathic pain, Active medical implant, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MH

Marshall Holland, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults with severe Restless Legs Syndrome that has not improved with standard treatments. Participants must have primary RLS and be willing to undergo a spinal cord stimulator implant.

Inclusion Criteria

My restless legs syndrome is severe and hasn't improved with standard treatments.
I am 18 years old or older.
Received a medical diagnosis of RLS via first screening with Cambridge Hopkins-RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire
See 3 more

Exclusion Criteria

I have nerve pain not caused by restless legs syndrome.
I do not have any mental or physical issues that stop me from completing study activities.
I have had a spinal cord stimulator trial or implant before.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline clinical, neuropsychological, and electrophysiological assessments

1-2 weeks

Treatment

Participants receive implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System

24 months
Regular follow-up visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Saluda Medical Evoke® Spinal Cord Stimulation System

Trial Overview

The study tests the safety and early effectiveness of an implanted device (Saluda Medical Evoke Spinal Cord Stimulation System) to help manage severe, hard-to-treat Restless Legs Syndrome over a period of 24 months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: SCS ImplantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Marshall Holland

Lead Sponsor

Trials
1
Recruited
20+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

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