Clinical trial NCT06076499: A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Restless Legs Syndrome
Keywords: RLS
Lead sponsor: Noctrix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 325
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of adults who meet the inclusion and exclusion criteria.

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.

Eligibility criteria: 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 is unable or unwilling to comply with study requirements.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 1 year
Secondary outcomes:
measure: CGI-I score at 1-year relative to baseline
timeFrame: 1 year
measure: PGI-I Score at 1-Year Relative to Baseline
timeFrame: 1 year
measure: Change from baseline in MOS-II total score at 1-year.
timeFrame: 1-year
measure: Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year
timeFrame: 1-year
Other outcomes:
measure: CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year.
timeFrame: 1-year
measure: CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".
timeFrame: 1-year
Locations:
city: Downey
country: United States
facility: Mark J Buchfuhrer, MD Office
state: California
city: San Ramon
country: United States
facility: Sleep Medicine Specialists of California
state: California
city: Newton
country: United States
facility: Neurocare, Inc.
state: Massachusetts
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Dublin
country: United States
facility: Ohio Sleep Medicine and Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
Study officials:
affiliation: Noctrix Health, Inc.
name: Jessica Preciado, PhD
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.
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.