Neuromodulation to Overcome Severe Restless Legs Syndrome

(NO RLS Trial)

CG
Overseen ByChris Gonzalez
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Marshall Holland
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?

What Are the Treatments Tested in This Trial?

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+