NCT05214963

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

Exploratory Clinical Study to Assess Tolerability, Safety, and Response to Non-invasive Peripheral Nerve Stimulation (NPNS) in Medication-naïve and Medication-refractory Restless Legs Syndrome (RLS) Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 22 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of a series of two 2-week phases: Phase 1: Baseline evaluation of RLS and sleep Phase 2: Prospective, single-blinded, 1:1 randomized evaluation of response to NPNS treatment (Active treatment: Sham control) Additionally, subjects will have the option to consent to a third phase, which includes overnight polysomnography (PSG) evaluation of sleep with Active treatment and with no treatment (baseline), in randomized order.

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

Timeline

• Start date: 2022-03-08
• Primary completion: 2023-07-24
• Completion: 2023-10-24
• First posted: 2022-01-31
• Last updated: 2023-12-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study