ClinicalTrials.gov
History of Changes for Study: NCT06076499
A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS (THRIVE)
Latest version (submitted February 20, 2024) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 October 6, 2023 None (earliest Version on record)
2 November 16, 2023 Study Status
3 December 8, 2023 Study Status and Contacts/Locations
4 February 12, 2024 Study Status and Contacts/Locations
5 February 20, 2024 Contacts/Locations and Study Status
Comparison Format:
Scroll up to access the controls
Study NCT06076499
Submitted Date:  October 6, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: CT-06
Brief Title: A Post-Market Study for Long-Term Effectiveness and Safety of the NTX100 for RLS (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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2023
Overall Status: Recruiting
Study Start: October 10, 2023
Primary Completion: June 2024 [Anticipated]
Study Completion: December 2025 [Anticipated]
First Submitted: September 26, 2023
First Submitted that
Met QC Criteria:		 October 6, 2023
First Posted: October 10, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 October 6, 2023
Last Update Posted: October 10, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Noctrix Health, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Restless Legs Syndrome
Keywords: RLS
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 325 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
Device: NTX100
NTX100 Tonic Motor Activation (TOMAC) System - a non-invasive peripheral nerve stimulation device programmed to deliver active stimulation.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Primary Effectiveness Endpoint
[ Time Frame: 1 year ]

Change from baseline (study entry) in IRLS total score at 1-year.
Secondary Outcome Measures:
1. CGI-I score at 1-year relative to baseline
[ Time Frame: 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).
2. PGI-I Score at 1-Year Relative to Baseline
[ Time Frame: 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).
3. Change from baseline in MOS-II total score at 1-year.
[ Time Frame: 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.
4. Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year
[ Time Frame: 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:
1. CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year.
[ Time Frame: 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.
2. CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".
[ Time Frame: 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.
Open or close this module Eligibility
Study Population: The study population will consist of adults who meet the inclusion and exclusion criteria.
Sampling Method: Probability Sample
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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 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
Open or close this module Contacts/Locations
Central Contact Person: Jessica Preciado, PhD
Telephone: 5103331437
Email: jessica@noctrixhealth.com
Central Contact Backup: Jonathan D Charlesworth, PhD
Telephone: 8046834279
Email: jcharlesworth@noctrixhealth.com
Study Officials: Jessica Preciado, PhD
Study Director
Noctrix Health, Inc.
Locations: United States, California
Mark J Buchfuhrer, MD Office
[Recruiting]
Downey, California, United States, 90241
Contact:Contact: Mark J Buchfuhrer, MD 562-904-1101 mjbuchfuhrer@gmail.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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 33949942
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. PubMed 36856064
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. PubMed 37458698
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. PubMed 37439365
Links: Description: Noninvasive neuromodulation reduces symptoms of restless legs syndrome
Description: Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms
Description: Efficacy and safety of tonic motor activation (TOMAC) for medication-refractory restless legs syndrome: a randomized clinical tria
Description: Long-term efficacy and safety of tonic motor activation for treatment of medication-refractory restless legs syndrome
Available IPD/Information:
Scroll up to access the controls Scroll to the Study top
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services