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

This study is looking at a new way to help people with Restless Legs Syndrome (RLS). It's testing an investigational device called Extended Duration (XD-) TOMAC Therapy, which provides gentle stimulation, and also Tonic Motor Activation (TOMAC) Therapy. The goal is to see if these devices are safe, well-tolerated, and can reduce how often you wake up at night because of RLS. You might be able to join if you have a medical diagnosis of RLS, are at least 21 years old, and can understand English. The study is planning to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with 20 planned participants, testing a medical device. The study is 12 weeks long and involves different phases of device use.
What's involved
You would use a noninvasive neuromodulation device at home, either nightly or for 30-minute sessions, for a total of 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which is the duration of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07675109

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

Recruiting
NAAges 21+InterventionalTreatment
Noctrix Health, Inc.
~20 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Investigational Extended Duration (XD-) TOMAC TherapyTonic Motor Activation (TOMAC) Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of RLS-related awakenings per night
Measured over 12 weeks

Conditions

Restless Legs Syndrome (RLS)

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NCT07675109

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Noctrix Health Headquarters

    Pleasanton, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jonathan D Charlesworth, PhD · PRINCIPAL_INVESTIGATOR · Noctrix Health

Who to contact

Clinical Research Coordinator
[email protected]
415-531-1578
Email the study team

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Eligibility criteria

Inclusion

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
Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure).
Subject reports that RLS symptoms are most significant in lower legs and/or feet.
Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry.
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.
Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale).
Subject is 21 years of age or older.

Exclusion

The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
The subject has been diagnosed with epilepsy or other seizure disorder.
The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
The subject is unable or unwilling to comply with study requirements.
The subject has a medical condition not listed above that may put them at risk.
Subject has prior experience with neurostimulation devices developed by the study sponsor
Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.
Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
Subject reports a habitual sleep schedule that is not primarily aligned with nighttime hours (bedtime 8:00pm-2:00am and morning awakening 4:00am-11:00am), or reports that bedtime regularly varies by more than 4 hours (e.g., due to shift work or an inconsistent sleep schedule).
Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms or sleep, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines.
Subject has changed dose or schedule of medication or treatment that is likely to impact RLS symptoms or sleep in the past 30 days, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP.
During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range

What this trial measures

  • Number of RLS-related awakenings per night12 weeks

    This outcome measures the number of awakenings per night that were related to RLS symptoms. A lower number represents a better outcome. Assessed via daily sleep diary and compared for each intervention to the Baseline period