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

Noctrix Health, Inc.6 sites in 1 country325 target enrollmentNovember 15, 2023

ConditionsRestless Legs Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Restless Legs Syndrome
Sponsor: Noctrix Health, Inc.
Enrollment: 325
Locations: 6
Primary Endpoint: Primary Effectiveness Endpoint
Status: Active, Not Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 15, 2023

End Date

December 1, 2026

Last Updated

9 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Noctrix Health, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

•The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators)
•The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
•The subject has been diagnosed with one of the following conditions:
•Epilepsy or other seizure disorder
•The subject has a moderate or severe cognitive disorder or mental illness.
•The subject has a known allergy to device materials (or a previous severe reaction to medical adhesives or bandages).
•Subject has any of the following at or near the location of the device application:
•Acute injury
•Cellulitis
•Open sores

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)