Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic A… (NCT07397247) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation
Austria50 participantsStarted 2026-04
Plain-language summary
This study evaluates Tonic Motor Activation (TOMAC) therapy in adults with restless legs syndrome and dopaminergic augmentation. Participants use a noninvasive peroneal nerve stimulation device over a defined treatment period to assess symptom response and medication use.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult 18 years of age or older when written informed consent is obtained.
* Diagnosis of restless legs syndrome confirmed by IRLSSG criteria.
* Moderate-severe RLS, IRLS ≥15 points at study entry
* Dopaminergic augmentation based on clinician assessment and ASRS (augmentation severity rating scale) ≥5 points at study entry
* Subject agrees to not change the dose or schedule of antidepressants and sleep medications.
* Currently taking stable dose and schedule of dopamine agonist over the 4 weeks prior to enrollment, with average daily dose \>= 25mg Levodopa Equivalent Daily Dose (LEDD, https://pdmedcalc.co.uk/calculator).
* Patient reports ≥3 nights per week in the 30d prior to study entry: waking during the sleep period with RLS symptoms that interfered with sleep re-initiation
* RLS sensory symptoms in lower legs and/or feet are equally or more distressing than RLS sensory symptoms in all other anatomical locations.
* 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 and can understand the requirements of the study and instructions for device usage.
Exclusion Criteria:
* Baseline ferritin \<75 ng/mL or patient is unwilling to consider iron supplementation.
* IV iron sup…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in IRLS total score at Week 8 relative to Baseline (study entry)