What is this study trying to find out about Restless Legs Syndrome (RLS)?

This study is evaluating an investigational device that delivers extended-duration neuromodulation therapy to reduce symptoms of RLS. Researchers want to understand how well the device is tolerated, its safety, and its impact on sleep and symptom severity. The study is sponsored by Noctrix Health, Inc.

Who may be eligible for this Restless Legs Syndrome clinical trial?

Adults aged 21 and older with a medical diagnosis of primary RLS and moderate to severe symptoms may be eligible. Participants must have RLS symptoms mainly in their lower legs or feet and experience symptom-related awakenings at least three nights per week. Please review eligibility criteria for more details.

Is there any cost to participate in this Restless Legs Syndrome clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 21Years +

All Genders

ID07675109

Study Evaluating Extended Duration TOMAC Therapy Using a Noninvasive Device for Restless Legs Syndrome Treatment

Led by Noctrix Health, Inc. · Updated on 2026-06-30

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate an investigational noninvasive neuromodulation device for treating Restless Legs Syndrome RLS. The study focuses on assessing how well participants tolerate the device, its safety, and its effects on RLS symptoms, including the number of awakenings related to RLS during the night. The device has been designated as non-significant risk by the institutional review board IRB. The study lasts 12 weeks, beginning with a 1-week baseline period without intervention, followed by 1 week of Tonic Motor Activation TOMAC therapy involving 30-minute stimulation sessions. After this, participants undergo 4 weeks of Extended Duration XD- TOMAC therapy nightly. In the final 6 weeks, participants use the investigational device with different therapy settings in a pseudo-randomized order across three 2-week periods to assess varying stimulation waveforms. During the study, participants set up and use the device at bedtime as instructed. Researchers monitor sleep quality and RLS symptoms through various measures, including nightly awakenings, symptom severity scales, sleep efficiency, and patient-reported improvement. Participants complete electronic questionnaires and communicate with the study staff remotely throughout the home-based study. The primary measure is the number of RLS-related awakenings over 12 weeks, with secondary measures assessing symptom changes and sleep quality.

CONDITIONS

Brief Title

Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)

Who Can Participate

Age: 21Years +

All Genders

Eligibility Criteria

You may qualify if you...

Subject has signed a valid informed consent form and can understand study requirements and device instructions
Subject has a medical diagnosis of primary restless legs syndrome (RLS)
Subject agrees not to change dosage or schedule of medications affecting RLS symptoms during the study
Subject reports RLS symptoms are most significant in lower legs and/or feet
Subject reports RLS symptoms cause awakenings or interfere with falling back asleep at least 3 nights per week
Subject has necessary equipment and communication ability for electronic questionnaires and communications
Subject has moderate to severe RLS symptoms with an IRLS score of 15 or greater
Subject is 21 years of age or older

You will not qualify if you...

Subject has an active implanted medical device anywhere in the body
Subject has a metal implant at the device application site (excluding knee replacements)
Subject has epilepsy or other seizure disorder
Subject has moderate or severe cognitive disorder or mental illness affecting study participation
Subject has allergy to device materials or severe reaction to medical adhesives
Subject has acute injury, cellulitis, or open sores near device application site
Subject is unable or unwilling to comply with study requirements
Subject has medical conditions that may increase risk
Subject has prior experience with neurostimulation devices from the study sponsor
Subject has a primary sleep disorder other than RLS that significantly interferes with sleep
Subject has typical sleep onset latency over 60 minutes on nights without RLS symptoms
Subject has severe peripheral neuropathy affecting lower legs or cannot distinguish neuropathy from RLS symptoms
Subject has a habitual sleep schedule not primarily aligned with nighttime hours or irregular bedtime
Subject is taking unstable or inconsistent doses of medications likely to impact RLS symptoms or sleep
Subject has changed medication or treatment doses impacting RLS symptoms or sleep within the past 30 days
Device does not properly fit or calibrate during initial setup

Research Team

Clinical Research Coordinator

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Study Evaluating Extended Duration TOMAC Therapy Using a Noninvasive Device for Restless Legs Syndrome Treatment

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria