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

Sponsor

Noctrix Health, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06076499

Collaborator

(none)

325

Enrollment

Location

25.7

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Device: NTX100

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

Anticipated Enrollment :

325 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Primary Effectiveness Endpoint [1 year]
Change from baseline (study entry) in IRLS total score at 1-year.

Secondary Outcome Measures

CGI-I score at 1-year relative to baseline [1 year]
The 1-year Clinical Global Impression-Improvement (CGI-I) score assesses a patient's overall condition relative to their baseline, indicating treatment effectiveness and change in condition over a year. Scores range from 1 (very much improved) to 7 (very much worse).
PGI-I Score at 1-Year Relative to Baseline [1 year]
The 1-year Patient Global Impression-Improvement (PGI-I) score assesses the patient's perception of their condition's improvement from baseline, with scores ranging from 1 (very much improved) to 7 (very much worse).
Change from baseline in MOS-II total score at 1-year. [1-year]
The Medical Outcomes Study 36-Item Short Form Health Survey (MOS-II) measures various aspects of a patient's health-related quality of life. This endpoint assesses the change in the total MOS-II score at the 1-year mark compared to the baseline, and how the treatment impacts overall well-being over the course of a year.
Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year [1-year]
This endpoint focuses on Restless Legs Syndrome (RLS) and assesses the change in symptom frequency over a year. It quantifies the reduction in the number of days per week that a patient experiences RLS symptoms, indicating the treatment's effectiveness in managing this condition over time.

Other Outcome Measures

CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year. [1-year]
This metric gauges the proportion of patients showing significant improvement after one year of treatment, defined as a "Very Much Improved" or "Much Improved" CGI-I response.
CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved". [1-year]
This measure indicates the percentage of patients experiencing positive change due to treatment, encompassing "Very Much Improved," "Much Improved," and "Minimally Improved" CGI-I responses.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

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

The subject is unable or unwilling to comply with study requirements.
The subject is pregnant or trying to become pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mark J Buchfuhrer, MD Office	Downey	California	United States	90241

Sponsors and Collaborators

Noctrix Health, Inc.

Investigators

Study Director: Jessica Preciado, PhD, Noctrix Health, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Noctrix Health, Inc.

ClinicalTrials.gov Identifier:

NCT06076499

Other Study ID Numbers:

CT-06

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Noctrix Health, Inc.

RLS

Additional relevant MeSH terms:

Psychomotor Agitation

Restless Legs Syndrome

Syndrome

Study Results

No Results Posted as of Oct 10, 2023