[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Salvia BioElectronics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100648396","trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-100648396",false,"NCT07719608","A Pivotal Clinical Study to Evaluate the MySalvia System for the Treatment of Resistant Migraine","Randomized, Double-Blind, Controlled Pivotal Trial of the MySalvia System for the Treatment of Resistant Migraine","RECLAIM-II","Inclusion Criteria:\n\nMeets resistant migraine criteria:\n\n1. Documented diagnosis of 1.1 migraine without aura and\u002For 1.2 migraine with aura and\u002For 1.3 chronic migraine according to ICHD-3\n2. Headache requiring two of the following:\n\n   * Leads to considerable impairment in personal, educational and\u002For occupational areas of functioning (MIDAS rating of severe or very severe)\n   * Concomitant continuous or near continuous headache between migraine attacks\n   * Eight or more monthly migraine days\n3. Lack of 50% reduction in monthly migraine days and\u002For intolerable side effects and\u002For absolute contraindication to three or more (but not all) classes of at least one evidence-based medication. The classes must include Onabotulinumtoxin A and CGRP mabs\u002Fantagonists.\n4. Not better accounted for by another ICHD-3 diagnosis 4. History of migraine onset before 50 years of age 5. Stable dose of all preventive migraine medication(s) and alternative therapies for at least three months before the start of the eligibility phase\n\nExclusion Criteria:\n\n* Presence of another chronic primary or secondary headache disorder, unless the participant can reliably differentiate these headaches attacks from migraine attacks, based on the pain characteristics and associated symptoms\n* Concurrent use of any invasive or non-invasive neuromodulation.\n* Previous inadequate response to an implantable neuromodulation device for headache or pain management.\n* Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant).\n* Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.\n\nPresence of an active implantable medical device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implant).\n\n* Presence of metal or magnet implants in the skull or cranial region (e.g. skull plates, seeds)\n* Pregnant, nursing or not using contraception.","ALL","22 Years","84 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this pivotal clinical study is to evaluate the safety and effectiveness of the MySalvia System, a minimally invasive implantable neuromodulation therapy, for the preventive treatment of adults with resistant migraine.",[28,29,30,31],"Resistant Migraine","Chronic Migraine Headache","Headache (Migraine)","Headache, Cluster",[33,34,28,35,36],"Neuromodulation","Chronic Migraine","Headache","HIgh Frequency Episodic Migraines","RECRUITING","2026-08-12",{"date":40,"type":41},"2026-08-13","ACTUAL",{"date":43,"type":22},"2026-12-01",{"date":45,"type":22},"2031-05-01",{"name":47,"class":48},"Salvia BioElectronics","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100550697","the-reclaim-study-100550697","NCT06450444","The RECLAIM Study.","Randomized, Double-blind, Controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.","RECLAIM","Inclusion Criteria:\n\n* Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening\n* Failure of 3 or more preventive pharmacological therapies\n* Stable on preventive migraine treatments\n* Psychologically stable\n\nExclusion Criteria:\n\n* Concomitant invasive or non-invasive neuromodulation\n* Previous exposure to an implantable neuromodulation device for headache\n* Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)\n* Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.\n* Use of local corticosteroid injections in the occipital or supra-orbital region in the past 3 months prior to enrollment.\n* Not pregnant, nursing or not using contraception","18 Years",{"count":60,"type":22},110,[25],"The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.",[34,64],"High Frequency Episodic Migraine","2026-08-05",{"date":67,"type":41},"2026-08-06",{"date":69,"type":41},"2024-06-24",{"date":71,"type":22},"2029-01-31",{"name":47,"class":48},11,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":49},"100601667","response-to-combined-trigeminal-and-occipital-nerve-stimulation-for-the-preventive-treatment-in-chronic-cluster-headache-100601667","NCT07113470","Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache","Response to Combined Trigeminal and Occipital Nerve Stimulation for the Preventive Treatment in Chronic Cluster Headache: The RESPONSE-II Study","SalviaBio","Inclusion Criteria:\n\n1. Able and willing to provide informed consent\n2. 18 years of age or older\n3. Documented Primary Chronic Cluster Headache, for at least 1 year as per ICHD-3 criteria\n\nExclusion Criteria:\n\n1. Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from cluster headache attacks based on the quality and associated symptoms\n2. Secondary Cluster Headache",{"count":83,"type":22},10,[25],"This is a limited open-label study being performed at two centers in the Netherlands. All participants will receive the same treatment, and both the patients and doctors will know what that treatment is. The goal is to see how safe and effective the PRIMUS system is for preventing Chronic Cluster Headaches (CCH) in people who haven't responded well to the drug verapamil. The study will also look at the patients' experience using the system.",[87],"Chronic Cluster Headache","2026-07-14",{"date":90,"type":41},"2026-07-16",{"date":92,"type":41},"2026-04-13",{"date":94,"type":22},"2028-12-01",{"name":47,"class":48},""]