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

Restless Legs Syndrome Clinical Trial

— THRIVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076499
• Other study ID #: CT-06
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Noctrix Health, Inc.
• Contact: Jessica Preciado, PhD
• Phone: 5103331437
• Email: jessica[@]noctrixhealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: December 2026
• Est. primary completion date: June 2025
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Mark J Buchfuhrer, MD Office	Downey	California
United States	Ohio Sleep Medicine and Institute	Dublin	Ohio
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Sleep Medicine Specialists of California	San Ramon	California
United States	Southern California Pulmonary and Sleep Disorders Medical Center	Thousand Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Noctrix Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bogan RK, Roy A, Kram J, Ojile J, Rosenberg R, Hudson JD, Scheuller HS, Winkelman JW, Charlesworth JD. Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical trial. Sleep. 2023 Oct 11;46(10):zsad190. doi: 10.1093/sleep/zsad190. — View Citation

Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404. — View Citation

Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536. — View Citation

Roy A, Ojile J, Kram J, Olin J, Rosenberg R, Hudson JD, Bogan RK, Charlesworth JD. Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome: A 24-Week Open-Label Extension Study. Sleep. 2023 Oct 11;46(10):zsad188. doi: 10.1093/sleep/zsad188. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 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.	1-year
Other	CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".	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.	1-year
Primary	Primary Effectiveness Endpoint	Change from baseline (study entry) in IRLS total score at 1-year.	1 year
Secondary	CGI-I score at 1-year relative to baseline	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).	1 year
Secondary	PGI-I Score at 1-Year Relative to Baseline	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).	1 year
Secondary	Change from baseline in MOS-II total score at 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.	1-year
Secondary	Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 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.	1-year

External Links

•   Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms
•   Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical tria
•   Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome
•   Noninvasive neuromodulation reduces symptoms of restless legs syndrome