MedTrace Logo

Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)

NCT04874155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2024-10-08

Study results available
· View outcomes & findings →

Summary

Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary RLS

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.

DEVICE

NTX100 Neuromodulation System - Open-Label

Noninvasive peripheral nerve stimulation device programmed to active mode.

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2022-03-18
Completion
2022-04-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04874155 on ClinicalTrials.gov