An interventional study of Tonic Motor Activation (TOMAC) Device in Restless Legs Syndrome, sponsored by Noctrix Health, Inc.. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Noctrix Health, Inc. (part of ResMed) · Not applicable, Interventional, and Treatment
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Among 11 studies in Restless Legs Syndrome with a site in Austria — 1 open to participants now, 1 under way, none of them phase 3. Restless Legs Syndrome · Austria.
Among the 11 studies in Restless Legs Syndrome with a site in Austria, this one is the 9th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is the only one with no phase, and was the 11th registered.
259 studies on the registry are indexed under Restless Legs Syndrome; 38 are open to participants now.
Browse Restless Legs Syndrome studies →1 of the 11 studies in Restless Legs Syndrome with a site in Austria is open now.
A study can be open while its sites in Austria have not opened yet or have stopped. Only those recruiting at a site in Austria →
Of the 25 Restless Legs Syndrome studies recruiting now, 10 (40%) set no upper age limit and 12 (48%) stop at 75 or younger; none take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 53 across 200 interventional studies indexed under Restless Legs Syndrome.
Median enrollment 313 across the 10 interventional studies, 549 across the 1 observational. Of the 10 that completed or were terminated, 6 (60%) have results posted.
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10 of 11 have an industry lead sponsor. The 8 most frequent:
This study is registered under Noctrix Health, Inc., one of the names counted as ResMed. Under that name alone:
Noctrix Health, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
ResMed has 9 studies filed under Restless Legs Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Restless Legs Syndrome with a site in Austria that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07397247Noctrix Health, Inc.Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation | 2027-01 |
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Among the 11 studies in Restless Legs Syndrome with a site in Austria, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive Tonic Motor Activation (TOMAC) therapy using noninvasive peroneal nerve stimulation with investigational settings and are followed over a defined treatment period.
Device: Tonic Motor Activation (TOMAC) Device
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.
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.
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
Plan to share: No — Individual participant data (IPD) will not be shared for this study due to the investigational nature of the device and sponsor data governance and confidentiality considerations.
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Jan 2027, 9 months later.
Of 53 interventional studies with no phase under Restless Legs Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 40. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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