NCT06076499

A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS

A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix NTX100 TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 325 (estimated)
• Sponsor: Noctrix Health, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

Summary

Multi-center post-market, observational study to assess the long-term effectiveness and safety of the NTX100 TOMAC System for patients with Restless Legs Syndrome.

Detailed description

This study will assess the NTX100 TOMAC System's long-term effectiveness and safety in real-world settings. Using a prospective, observational approach, we'll monitor individuals receiving the system as part of standard care through five study visits, collecting data on clinical outcomes, device performance, and adverse events.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DEVICE	NTX100	NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-10-10
• Last updated: 2025-07-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study