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

NCT06076499 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 325

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Restless Legs Syndrome

Interventions

DEVICE

NTX100

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

Sponsors & Collaborators

  • Noctrix Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Jessica Preciado, PhD · Noctrix Health, Inc.

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2026-07-31
Completion
2027-07-31
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 NCT06076499 on ClinicalTrials.gov