Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation

NCT07397247 | Not Yet Recruiting FDA Device

• 1 other identifier: CT-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Restless Legs Syndrome

Keywords

Tonic Motor Activation; TOMAC; Dopaminergic augmentation; Peripheral nerve stimulation; Sleep disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  8 Weeks

Secondary Outcomes (10)

• Change in MOS-II total score at Week 8 relative to Baseline (study entry)

  8 Weeks

• PGI-I responder rate, defined as a PGI-I response of "Very Much Improved" or "Much Improved" at Week 8

  8 Weeks

• CGI-I responder rate, defined as a CGI-I response of "Very Much Improved" or "Much Improved" at Week 8

  8 Weeks

• Change in Frequency of RLS symptoms (days/week) at Week 8 relative to Baseline (study entry).

  8 Weeks

• Change in Sleep Efficiency percentage at Week 8 compared to baseline (Study entry).

  8 weeks

Study Arms (1)

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.

Device: Tonic Motor Activation (TOMAC) Device

Interventions

Tonic Motor Activation (TOMAC) Device 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.

TOMAC Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Noctrix Health, Inc.: lead

Study Sites (1)

Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)