[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"headache-cluster\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:headache-cluster":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100576621","spg-pulsed-radiofrequency-for-chronic-cluster-headache-100576621","NCT06787677","SPG Pulsed Radiofrequency for Chronic Cluster Headache","The Efficacy and Safety of Sphenopalatine Ganglion Pulsed Radiofrequency Treatment for Chronic Cluster Headache","Inclusion Criteria:\n\n* Chronic cluster headache;\n* At least four attacks per week;\n* Minimum age of 18 years;\n* Non-response to verapamil and lithium treatment in the past, intolerance, or contraindication to verapamil and lithium, along with non-response, intolerance, or contraindica-tion to topiramate, or gabapentin.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding;\n* Presence of cardiac pacemaker or other neuromodulatory devices;\n* Pyschiatric and cognitive disorders;\n* Serious drug habituation or overuse of acute-headache medication;\n* History of stroke or intracranial aneurysm, or at risk for serious or acute cardiovascular events;\n* Infection at the puncture site;\n* Previous history of invasive treatments such as sphenopalatine ganglion radiofrequency thermocoagulation and chemical destruction.","18 Years",{"count":59,"type":22},108,[25],"Cluster headache (CH) is a devastating disorder characterized by ipsilateral headache and associated trigeminal autonomic symptoms, with a yearly prevalence of 0.1%. There is a huge clinically unmet demand for an effective therapeutic method for CH. Previous evidences indicate that pulse radiofrequency (PRF) targeting the sphenopalatine ganglion (SPG) is a safe, minimally invasive, effective treatment for CH. This randomized, controlled trial aimed to establish the safety and efficacy of SPG PRF for patients with chronic CH.",[31],"2025-01-23",{"date":65,"type":41},"2025-01-27",{"date":67,"type":41},"2025-01-24",{"date":69,"type":22},"2030-12-31",{"name":71,"class":72},"Beijing Tiantan Hospital","OTHER"]