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Clinical Trials/NCT06076499
NCT06076499Active, not recruitingNot Applicable

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

Noctrix Health, Inc.13 sites in 1 country325 target enrollmentStarted: November 15, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
325
Locations
13
Primary Endpoint
Primary Effectiveness Endpoint
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
  • •The subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.
  • •Diagnosis of restless legs syndrome.

Exclusion Criteria

  • •1. The subject is unable or unwilling to comply with study requirements.

Outcomes

Primary Outcomes

Primary Effectiveness Endpoint

Time Frame: 1 year

Change from baseline (study entry) in IRLS total score at 1-year.

Secondary Outcomes

  • CGI-I score at 1-year relative to baseline(1 year)
  • PGI-I Score at 1-Year Relative to Baseline(1 year)
  • Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year(1-year)
  • Change from baseline in MOS-II total score at 1-year.(1-year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (13)

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