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
Single group
Tonic Motor Activation (TOMAC) Device
DeviceTonic Motor Activation (TOMAC) therapy is delivered using a noninvasive peroneal nerve stimulation device. Participants use the device according to the study protocol over a defined treatment period. The device is used by participants in the home setting according to study instructions.
Change in IRLS total score at Week 8 relative to Baseline (study entry)
The International Restless Legs Syndrome Study Group (IRLS) Rating Scale is a participant-reported questionnaire assessing the severity of restless legs syndrome symptoms, with total scores ranging from 0 to 40, where higher scores indicate greater severity. The outcome is the change in IRLS total score from baseline (study entry) to Week 8.
Change in MOS-II total score at Week 8 relative to Baseline (study entry)
The Medical Outcomes Study Sleep Problems Index II (MOS-II) score is a subscale of the participant-rated MOS questionnaire that measures subjective sleep quality. The MOS-I (6-items) and MOS-II (9-items) are the two validated subscales of the 12-item MOS Sleep Scale. Both are scored from 0 to 100, where 100 corresponds to the worst possible sleep problems and 0 corresponds to no sleep problems. The mean change is assessed from study entry to Week 8, and the endpoint is evaluated over the past two weeks.
PGI-I responder rate, defined as a PGI-I response of "Very Much Improved" or "Much Improved" at Week 8
The PGI-I Responder Rate is the percentage of subjects with a Patient Global Impressions of Improvement (PGI-I) rating of Much Improved or Very Much Improved relative to study entry. The scores for the Patient Global Impressions of Improvement (PGI-I) are: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). Higher percentage corresponds to better outcome. This outcome will be evaluated at Week 8 relative to study entry.
CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved" at Week 8
The CGI-I responder rate is the percentage of subjects with a Clinical Global Impressions of Improvement (CGI-I) rating of Much Improved or Very Much Improved relative to study entry. The scores for the Clinical Global Impressions of Improvement (CGI-I) are: Very Much Improved (1), Much Improved (2), Minimally Improved (3), No Change (4), Minimally Worse (5), Much Worse (6), Very Much Worse (7). Higher percentage corresponds to better outcome. This outcome will be evaluated at Week 8 relative to study entry.
Change in Frequency of RLS symptoms (days/week) at Week 8 relative to Baseline (study entry).
This outcome measures the change in subject-reported number of nights with RLS, derived from a follow up to question 7 of the International Restless Legs Syndrome Study Group (IRLS) questionnaire. The value ranges from 0 to 7 for each time point assessed. The mean change is assessed from study entry to Week 8. A greater decrease represents a better outcome.
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