[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Noctrix Health, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644906","optimizing-extended-duration-xd--tomac-therapy-for-restless-legs-syndrome-rls-100644906",false,"NCT07675109","Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)","Form, Fit and Function Feasibility Study","Inclusion Criteria:\n\n* Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English\n* Subject has received a medical diagnosis of primary restless legs syndrome (RLS).\n* Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure).\n* Subject reports that RLS symptoms are most significant in lower legs and\u002For feet.\n* Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry.\n* The subject possesses the necessary equipment, internet\u002Fphone 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.\n* Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale).\n* Subject is 21 years of age or older.\n\nExclusion Criteria:\n\n* The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).\n* The subject has a metal implant at the site of the study device electrode application (not including knee replacements).\n* The subject has been diagnosed with epilepsy or other seizure disorder.\n* The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.\n* The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).\n* Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores\n* The subject is unable or unwilling to comply with study requirements.\n* The subject has a medical condition not listed above that may put them at risk.\n* Subject has prior experience with neurostimulation devices developed by the study sponsor\n* Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).\n* On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \\>60min.\n* Subject has severe peripheral neuropathy affecting the lower legs and\u002For subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.\n* Subject reports a habitual sleep schedule that is not primarily aligned with nighttime hours (bedtime 8:00pm-2:00am and morning awakening 4:00am-11:00am), or reports that bedtime regularly varies by more than 4 hours (e.g., due to shift work or an inconsistent sleep schedule).\n* Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms or sleep, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines.\n* Subject has changed dose or schedule of medication or treatment that is likely to impact RLS symptoms or sleep in the past 30 days, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP.\n* During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range","ALL","21 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.\n\nThe IRB has established that the investigational device is non-significant risk.",[26],"Restless Legs Syndrome (RLS)",[28,29,30,31],"TOMAC","stimulation","neuromodulation","RLS","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2026-06-08",{"date":40,"type":20},"2027-06",{"name":42,"class":43},"Noctrix Health, Inc.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100623485","tonic-motor-activation-tomac-therapy-in-patients-with-restless-legs-syndrome-and-dopaminergic-augmentation-100623485","NCT07397247","Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation","Evaluating Response to Tonic Motor Activation (TOMAC) Therapy for Patients With Restless Legs Syndrome and Dopaminergic Augmentation","CT-10","Inclusion Criteria:\n\n* Adult 18 years of age or older when written informed consent is obtained.\n* Diagnosis of restless legs syndrome confirmed by IRLSSG criteria.\n* Moderate-severe RLS, IRLS ≥15 points at study entry\n* Dopaminergic augmentation based on clinician assessment and ASRS (augmentation severity rating scale) ≥5 points at study entry\n* Subject agrees to not change the dose or schedule of antidepressants and sleep medications.\n* 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:\u002F\u002Fpdmedcalc.co.uk\u002Fcalculator).\n* 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\n* RLS sensory symptoms in lower legs and\u002For feet are equally or more distressing than RLS sensory symptoms in all other anatomical locations.\n* The subject possesses the necessary equipment, internet\u002Fphone 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.\n* The subject has signed a valid, IRB-approved informed consent form and can understand the requirements of the study and instructions for device usage.\n\nExclusion Criteria:\n\n* Baseline ferritin \\\u003C75 ng\u002FmL or patient is unwilling to consider iron supplementation.\n* IV iron supplementation in the 6 months prior to study entry.\n* Change to dose of RLS prescription medication(s) in the 4 weeks prior to study entry.\n* Medications that are known to exacerbate RLS symptoms, including: Sedative antihistamines, Tri\u002Ftetracyclics, MAOIs, SSRIs and SNRIs, Tramadol, Neuroleptics, Antiemetics, or the anticonvulsants Phenytoin or Methsuximid\n* Change in medication that is known to affect RLS symptoms in the 4 weeks prior to study entry (e.g. sleep medication, antihistamines, antidepressants).\n* 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).\n* 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.\n* Subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.\n* During the initial investigational device titration process, sensation threshold \\>= 30mA or distraction threshold \\\u003C 15mA, or the device does not properly fit the subject.\n* 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\\\u003C26) or mental illness, Moderate-severe edema affecting the lower legs\n* 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.\n* Known to be pregnant or trying to become pregnant.\n* Medical condition not listed above that may affect validity of the study or put the subject at risk as determined by the investigator.\n* Subject is using another investigational device or drug during the study.\n* 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.","18 Years",{"count":55,"type":20},50,[23],"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.",[59],"Restless Legs Syndrome",[61,28,62,63,64],"Tonic Motor Activation","Dopaminergic augmentation","Peripheral nerve stimulation","Sleep disorder","NOT_YET_RECRUITING","2026-02-02",{"date":68,"type":36},"2026-02-09",{"date":70,"type":20},"2026-04",{"date":72,"type":20},"2027-01",{"name":42,"class":43},""]