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.
This study includes a 24-week period during which participants use Tonic Motor Activation (TOMAC) therapy delivered by a noninvasive peroneal nerve stimulation device with investigational settings, including the option for extended-duration stimulation. Participants are prospectively assigned to receive TOMAC therapy according to a predefined, multi-stage study protocol. The study consists of two phases: an initial 8-week period of stable medication use with device therapy, followed by a 16-week period during which dopamine agonist medication tapering may occur while device therapy continues, as clinically appropriate. While statistical power calculations indicate that approximately 15 evaluable participants are sufficient for the primary endpoint, up to 50 participants may be enrolled to improve estimate precision and account for attrition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Tonic 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.
Medical University of Innsbruck
Innsbruck, Tyrol, Austria
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.
Time frame: 8 Weeks
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.
Time frame: 8 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.
Time frame: 8 Weeks
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.
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Time frame: 8 Weeks
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.
Time frame: 8 Weeks
Change in Sleep Efficiency percentage at Week 8 compared to baseline (Study entry).
Sleep efficiency (SE) is the percentage of the time a person spends asleep relative to the total time dedicated to sleep. A greater increase corresponds to a better outcome. During the study, participants will report bedtime, wake-up time, sleep onset latency (SOL), and time awake after sleep onset (WASO) on a daily diary. To compute SE percentage: Time in bed (TIB) will be computed as the time between bedtime and wake-up time, Total sleep time (TST) will be computed as (TIB-SOL-WASO), sleep efficiency (SE) percentage will be calculated as 100%\*(TST/TIB). For each individual participant, the Week 8 data point will correspond to the average of that participant's daily sleep diary responses in Weeks 7 and 8. For each individual participant, the baseline values will be collected at study entry, by asking the participant to recall the average value over the prior 2-week period.
Time frame: 8 weeks
Change in Minutes Awake after Sleep Onset (WASO) at Week 8 relative to baseline (study entry).
Minutes Awake after Sleep Onset (WASO) refer to the total number of minutes awake after first going to sleep and before waking up for the next day in the morning. Greater decrease in WASO corresponds to a better outcome. During the study, participants will report WASO minutes on a daily diary. For each individual participant, the Week 8 data point will correspond to the average of that participant's daily sleep diary responses in Weeks 7 and 8. For each individual participant, the baseline values will be collected at study entry, by asking the participant to recall the average value over the prior 2-week period
Time frame: 8 Weeks
Reducer Rate at Week 24 relative to baseline (Study entry).
This outcome assesses the percentage of patients who reduced the Levodopa Equivalent Daily Dose (LEDD) of their RLS medication at Week 24 compared to baseline (study entry).
Time frame: 24 Weeks
RLS severity change at Week 24 compared to baseline (study entry).
Change in the International Restless Legs Syndrome Study Group (IRLS) Rating Scale Score, which is a participant rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. The mean change is assessed from study entry to Week 24.
Time frame: 24 Weeks
CGI-I responder rate at Week 24 relative to baseline (study entry)
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.
Time frame: 24 Weeks
Change in Levodopa Equivalent Daily Dose (LEDD) at Week 24 compared to baseline (study entry)
Dopaminergic medication doses are converted to levodopa equivalent daily dose (LEDD) using a standardized conversion method. The outcome is the change in LEDD from baseline (study entry) to Week 24.
Time frame: 24 Weeks