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 range18 Years
SexALL
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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…
What they're measuring
1
Change in IRLS total score at Week 8 relative to Baseline (study entry)