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Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS

NCT05214963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-12-15

No results posted yet for this study

Summary

Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.

Conditions

  • Restless Legs Syndrome

Interventions

DEVICE

NTX100 Neuromodulation System - Active

Noninvasive peripheral nerve stimulation device programmed to active mode

DEVICE

NTX100 Neuromodulation System - Sham

Noninvasive peripheral nerve stimulation device programmed to sham mode

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D Charlesworth, PhD · Noctrix Health, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2023-07-24
Completion
2023-10-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214963 on ClinicalTrials.gov