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

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ClinicalTrials.gov Identifier: NCT06076499
Recruitment Status : Recruiting
First Posted : October 10, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Noctrix Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Restless Legs Syndrome Device: NTX100

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
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Study Type : Observational
Estimated Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 15, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

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

Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The study population will consist of adults who meet the inclusion and exclusion criteria.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06076499


Contacts
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Contact: Jessica Preciado, PhD 5103331437 jessica@noctrixhealth.com
Contact: Jonathan D Charlesworth, PhD 8046834279 jcharlesworth@noctrixhealth.com

Locations
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United States, California
Mark J Buchfuhrer, MD Office Recruiting
Downey, California, United States, 90241
Contact: Mark J Buchfuhrer, MD    562-904-1101    mjbuchfuhrer@gmail.com   
Sleep Medicine Specialists of California Recruiting
San Ramon, California, United States, 94583
Contact: Haramandeep Singh, MD       hsingh@isleepmd.com   
Southern California Pulmonary and Sleep Disorders Medical Center Recruiting
Thousand Oaks, California, United States, 91361
Contact: Ronald Popper, MD       r.popper@sleepmd4u.com   
United States, Missouri
Clayton Sleep Institute Recruiting
Saint Louis, Missouri, United States, 63123
Contact: Matthew Uhles, MS       UhlesM@claytonsleep.com   
Principal Investigator: Joseph Ojile, MD         
United States, Ohio
Ohio Sleep Medicine and Institute Recruiting
Dublin, Ohio, United States, 43017
Contact: Rianna West       rwest@sleepmedicine.com   
Principal Investigator: Asim Roy, MD         
United States, South Carolina
Bogan Sleep Consultants, LLC Recruiting
Columbia, South Carolina, United States, 29201
Contact: Heather Byrd       Heather.Byrd@bogansleep.com   
Principal Investigator: Richard K Bogan, MD         
Sponsors and Collaborators
Noctrix Health, Inc.
Investigators
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Study Director: Jessica Preciado, PhD Noctrix Health, Inc.
More Information
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Additional Information:

Publications:

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Responsible Party: Noctrix Health, Inc.
ClinicalTrials.gov Identifier: NCT06076499    
Other Study ID Numbers: CT-06
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Noctrix Health, Inc.:
RLS
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
 Neurobehavioral Manifestations
Aberrant Motor Behavior in Dementia
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders