NCT04874155

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

A Multi-Center, Randomized, Double-Blind, Sham-Controlled Study to Evaluate the NTX100 Neuromodulation System for Patients With Medication-Refractory Primary Restless Legs Syndrome (RLS) - The RESTFUL Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 133 (actual)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 79 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study consists of a series of two 4-week phases: Phase 1: Prospective, double-blinded, 1:1 randomized (Active treatment: Sham control) Phase 2: Prospective, non-randomized, non-blinded, Active treatment

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-06
• Primary completion: 2022-03-18
• Completion: 2022-04-08
• First posted: 2021-05-05
• Last updated: 2024-10-08
• Results posted: 2024-09-19

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study