Restless Legs SyndromeTHRIVENCT06076499
A Post-Market Study for Long-Term Effectiveness and Safety of the TOMAC System for RLS
An observational study of Restless Legs Syndrome, run by Noctrix Health, Inc. at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- NTX100
- Type of treatment
- Medical device
- How many people
- 325 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 Nov 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of adults who meet the inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 1. The subject is unable or unwilling to comply with study requirements.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Mark J Buchfuhrer, MD Office
Downey, California, 90241
Ohio Sleep Medicine and Institute
Dublin, Ohio, 43017
Neurocare, Inc.
Newton, Massachusetts, 02459
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Sleep Medicine Specialists of California
San Ramon, California, 94583
Clayton Sleep Institute
St Louis, Missouri, 63123
About this study
Official title: A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study
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.
Read the 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- NTX100
- Keywords
- RLS
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX100Device
NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Change from baseline (study entry) in IRLS total score at 1-year.
Measured: 1 year
Secondary outcomes (4)
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).
Measured: 1 year
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).
Measured: 1 year
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.
Measured: 1-year
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.
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Nov 2023
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noctrix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Preciado, PhD, Study director, Noctrix Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076499
- Sponsor's protocol ID
- CT-06
- Acronym
- THRIVE
- Status last verified
- May 2026
- First submitted
- 26 Sep 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 33949942Charlesworth 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.
PubMed 36856064Bogan 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.
PubMed 37458698Roy 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.
PubMed 37439365Singh H, Buchfuhrer MJ, Ojile J, Roy A, Thomas RJ, Bogan RK, Aggarwal A, Preciado J, Swartz KJ, Charlesworth JD. Real-world effectiveness and safety of tonic motor activation therapy for refractory restless legs syndrome: 90-day outcomes from the THRIVE prospective observational study. Sleep. 2026 Jun 3:zsag140. doi: 10.1093/sleep/zsag140. Online ahead of print.
PubMed 42231562
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Observational Clinical Study to Determine the Long-Term Effectiveness and Safety of the Noctrix TOMAC (Tonic Motor Activation) System for the Treatment of Restless Legs Syndrome - The THRIVE Study
- ClinicalTrials.gov ID
- NCT06076499
- Acronym / sponsor ID
- THRIVE / CT-06
- Conditions
- Restless Legs Syndrome
- Keywords
- RLS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Noctrix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults who meet the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. The subject is unable or unwilling to comply with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX100NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation. | Device | – |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 1 year
Change from baseline (study entry) in IRLS total score at 1-year.
4 secondary outcomes
CGI-I score at 1-year relative to baseline
Time frame: 1 year
PGI-I Score at 1-Year Relative to Baseline
Time frame: 1 year
Change from baseline in MOS-II total score at 1-year.
Time frame: 1-year
Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 33949942Buchfuhrer 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.
- Background: PubMed 36856064Charlesworth 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.
- Background: PubMed 37458698Bogan 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.
- Background: PubMed 37439365Roy 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.
- Derived from this study: PubMed 42231562Singh H, Buchfuhrer MJ, Ojile J, Roy A, Thomas RJ, Bogan RK, Aggarwal A, Preciado J, Swartz KJ, Charlesworth JD. Real-world effectiveness and safety of tonic motor activation therapy for refractory restless legs syndrome: 90-day outcomes from the THRIVE prospective observational study. Sleep. 2026 Jun 3:zsag140. doi: 10.1093/sleep/zsag140. Online ahead of print.
- Noninvasive neuromodulation reduces symptoms of restless legs syndromeLink provided by the sponsor.
- Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptomsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Preciado, PhD study director
Noctrix Health, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Noctrix Health, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076499, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.