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.
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
Baseline ferritin <75 ng/mL or patient is unwilling to consider iron supplementation.
IV iron supplementation in the 6 months prior to study entry.
Change to dose of RLS prescription medication(s) in the 4 weeks prior to study entry.
Medications that are known to exacerbate RLS symptoms, including: Sedative antihistamines, Tri/tetracyclics, MAOIs, SSRIs and SNRIs, Tramadol, Neuroleptics, Antiemetics, or the anticonvulsants Phenytoin or Methsuximid