Restless Legs SyndromeCT-10NCT07397247
Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation
A study testing Tonic Motor Activation (TOMAC) Device in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Tonic Motor Activation (TOMAC) Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
- Change in medication that is known to affect RLS symptoms in the 4 weeks prior to study entry (e.g. sleep medication, antihistamines, antidepressants).
- Primary sleep disorder other than RLS that significantly interferes with sleep at the time of screening visit (e.g. obstructive sleep apnea with adherent CPAP usage would not be an exclusion but typical sleep onset latency of >60min on nights without RLS symptoms would be an exclusion).
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- Irregular sleep schedule: subject reports that bedtime is typically outside of 21:00 - 03:00 or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
- Subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
- During the initial investigational device titration process, sensation threshold >= 30mA or distraction threshold < 15mA, or the device does not properly fit the subject.
- One or more of the following confounding comorbidities: Stage 4-5 chronic kidney disease or renal failure , Iron-deficient anemia, Severe cardiac disease (NYHA class IV), Movements disorder other than RLS (Parkinson's disease, Huntington's disease, dyskinesia, dystonia), Multiple Sclerosis , Moderate-severe cognitive disorder (MoCA<26) or mental illness, Moderate-severe edema affecting the lower legs
- One or more of the following contraindications to the investigational device: Diagnosis of epilepsy or other seizure disorder, Metal implant in upper fibula, Known allergy to device materials (or severe previous reaction to medical adhesives or bandages), Open sores, or injury at or near the location of therapy device application.
- Known to be pregnant or trying to become pregnant.
- Medical condition not listed above that may affect validity of the study or put the subject at risk as determined by the investigator.
- Subject is using another investigational device or drug during the study.
- Subject does not understand the study requirements or device instructions, does not have the ability to complete the study assessments, or is unable or unwilling to comply with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Eva-Lotte Schabbehard, MSc, +43 512 9003 71422, Eva-Lotte.Schabbehard@i-med.ac.at
Ambra Stefani, MD, PhD
About this study
Official title: Evaluating Response to Tonic Motor Activation (TOMAC) Therapy for Patients With Restless Legs Syndrome and Dopaminergic Augmentation
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.
Read the detailed description
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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Tonic Motor Activation (TOMAC) Device
- Keywords
- Tonic Motor Activation, TOMAC, Dopaminergic augmentation, Peripheral nerve stimulation, Sleep disorder
- Medical subject headings
- Restless Legs Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonic Motor Activation (TOMAC) DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TOMAC Therapy | Experimental | Participants receive Tonic Motor Activation (TOMAC) therapy using noninvasive peroneal nerve stimulation with investigational settings and are followed over a defined treatment period. Receives: Device: Tonic Motor Activation (TOMAC) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label interventional study in which all enrolled participants receive Tonic Motor Activation (TOMAC) therapy and are followed over a defined treatment period to assess response.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noctrix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397247
- Sponsor's protocol ID
- CT-10
- Acronym
- CT-10
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Response to Tonic Motor Activation (TOMAC) Therapy for Patients With Restless Legs Syndrome and Dopaminergic Augmentation
- ClinicalTrials.gov ID
- NCT07397247
- Acronym / sponsor ID
- CT-10 / CT-10
- Conditions
- Restless Legs Syndrome
- Keywords
- Tonic Motor Activation, TOMAC, Dopaminergic augmentation, Peripheral nerve stimulation, Sleep disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Noctrix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label interventional study in which all enrolled participants receive Tonic Motor Activation (TOMAC) therapy and are followed over a defined treatment period to assess response.
| Arm | Type | Receives |
|---|---|---|
| TOMAC Therapy | Experimental | Device: Tonic Motor Activation (TOMAC) DeviceParticipants receive Tonic Motor Activation (TOMAC) therapy using noninvasive peroneal nerve stimulation with investigational settings and are followed over a defined treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
- Change in medication that is known to affect RLS symptoms in the 4 weeks prior to study entry (e.g. sleep medication, antihistamines, antidepressants).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tonic Motor Activation (TOMAC) 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. | Device | TOMAC Therapy |
Primary outcome
Change in IRLS total score at Week 8 relative to Baseline (study entry)
Time frame: 8 Weeks
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.
10 secondary outcomes
Change in MOS-II total score at Week 8 relative to Baseline (study entry)
Time frame: 8 Weeks
PGI-I responder rate, defined as a PGI-I response of "Very Much Improved" or "Much Improved" at Week 8
Time frame: 8 Weeks
CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved" at Week 8
Time frame: 8 Weeks
Change in Frequency of RLS symptoms (days/week) at Week 8 relative to Baseline (study entry).
Time frame: 8 Weeks
Change in Sleep Efficiency percentage at Week 8 compared to baseline (Study entry).
Time frame: 8 weeks
Change in Minutes Awake after Sleep Onset (WASO) at Week 8 relative to baseline (study entry).
Time frame: 8 Weeks
Reducer Rate at Week 24 relative to baseline (Study entry).
Time frame: 24 Weeks
RLS severity change at Week 24 compared to baseline (study entry).
Time frame: 24 Weeks
CGI-I responder rate at Week 24 relative to baseline (study entry)
Time frame: 24 Weeks
Change in Levodopa Equivalent Daily Dose (LEDD) at Week 24 compared to baseline (study entry)
Time frame: 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical University of Innsbruck
Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonic Motor Activation (TOMAC) Device in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IRLS total score at Week 8 relative to Baseline (study entry) (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.