NCT06076499

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Nov 2023Jul 2027

First Submitted

Initial submission to the registry

September 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

September 26, 2023

Last Update Submit

April 28, 2026

Conditions

Restless Legs Syndrome

Keywords

RLS

Outcome Measures

Primary Outcomes (1)

  • Primary Effectiveness Endpoint

    Change from baseline (study entry) in IRLS total score at 1-year.

    1 year

Secondary Outcomes (4)

  • CGI-I score at 1-year relative to baseline

    1 year

  • PGI-I Score at 1-Year Relative to Baseline

    1 year

  • Change from baseline in MOS-II total score at 1-year.

    1-year

  • Change from Baseline in Frequency of RLS Symptoms (Number of Days per Week) at 1-Year

    1-year

Other Outcomes (2)

  • CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved", at 1-year.

    1-year

  • CGI-I improvement rate, defined as the percentage of patients with a CGI-I response of "Very Much Improved", "Much Improved" or "Minimally Improved".

    1-year

Interventions

NTX100DEVICE

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

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of adults who meet the inclusion and exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • \. The subject is unable or unwilling to comply with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mark J Buchfuhrer, MD Office

Downey, California, 90241, United States

Location

Sleep Medicine Specialists of California

San Ramon, California, 94583, United States

Location

Neurocare, Inc.

Newton, Massachusetts, 02459, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Ohio Sleep Medicine and Institute

Dublin, Ohio, 43017, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

Related Publications (4)

  • 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.

    PMID: 33949942BACKGROUND

  • 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.

    PMID: 36856064BACKGROUND

  • 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.

    PMID: 37458698BACKGROUND

  • 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.

    PMID: 37439365BACKGROUND

Related Links

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

  • Jessica Preciado, PhD

    Noctrix Health, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 10, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(6)