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

Recruiting

• Conditions: Restless Legs Syndrome

• Registration Number: NCT06076499
• Lead Sponsor: Noctrix Health, Inc.

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 Timeline

• Study First Submitted: 2023-09-26
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Study Start: 2023-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

1. 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.
2. 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.
3. Diagnosis of restless legs syndrome.

Exclusion Criteria

1. The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators)

2. The subject has a metal implant at the site of the study device electrode application (not including knee replacements).

3. The subject has been diagnosed with one of the following conditions:

   • Epilepsy or other seizure disorder

4. The subject has a moderate or severe cognitive disorder or mental illness.

5. The subject has a known allergy to device materials (or a previous severe reaction to medical adhesives or bandages).

6. Subject has any of the following at or near the location of the device application:

   • Acute injury
   • Cellulitis
   • Open sores

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

8. The subject is pregnant or trying to become pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	1 year	Change from baseline (study entry) in IRLS total score at 1-year.

Secondary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (6)

Neurocare, Inc.; 🇺🇸 Newton, Massachusetts, United States

Mark J Buchfuhrer, MD Office; 🇺🇸 Downey, California, United States

Sleep Medicine Specialists of California; 🇺🇸 San Ramon, California, United States

Clayton Sleep Institute; 🇺🇸 Saint Louis, Missouri, United States

Ohio Sleep Medicine and Institute; 🇺🇸 Dublin, Ohio, United States

Bogan Sleep Consultants, LLC; 🇺🇸 Columbia, South Carolina, United States