[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-frequency-episodic-migraine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-frequency-episodic-migraine":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100550697","the-reclaim-study-100550697",false,"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","ALL","18 Years","84 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29],"Chronic Migraine","High Frequency Episodic Migraine","RECRUITING","2026-03-26",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2024-06-24",{"date":38,"type":22},"2029-01-31",{"name":40,"class":41},"Salvia BioElectronics","INDUSTRY",11,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100588190","high-density-eeg-meg-wearable-eeg-comparison-of-quantitative-electroencephalographic-indicators-as-neurophysiological-markers-of-effectiveness-of-mindfulness-therapy-in-addition-to-standard-treatment-in-patients-with-high-frequency-episodic-migraine-100588190","NCT06938178","High-Density EEG-MEG-wearable EEG: Comparison of Quantitative Electroencephalographic Indicators as Neurophysiological Markers of Effectiveness of Mindfulness Therapy in Addition to Standard Treatment in Patients With High-frequency Episodic Migraine","MindMEEG","Inclusion Criteria:\n\n* Adult patients will be included who fulfil the ICHD-3 criteria \\[8\\] for HFEM, code 1.3-Chronic Migraine (characteristics similar to CM but with a frequency of 8-14 migraine days per month) with stable therapy in the 3 months prior to the start of Mindfulness treatment. If the therapy is changed during the screening visit, the patient will wait 3 months before starting Mindfulness treatment.\n\nExclusion Criteria:\n\n* in the presence of psychiatric comorbidities in the psychotic area, reported in the history or assessed by the clinician\n* if pregnant\n* in the presence of secondary headache comorbidities (e.g. idiopathic intracranial hypertension)\n* if they have undergone symptomatic abuse detoxification at least twice in the previous two years\n* if they have already undergone any kind of treatment with Mindfulness or meditation techniques",{"count":51,"type":22},40,"OBSERVATIONAL","Recent studies suggest that Mindfulness may be an effective treatment for migraine, reducing the frequency of attacks, depression, anxiety and improving quality of life. However, the pathophysiological mechanisms underlying the effectiveness are not yet fully known. The identification of neurophysiological markers may help to better understand the mechanisms on which Mindfulness acts in migraine sufferers and to develop increasingly targeted and personalized Mindfulness interventions to optimize migraine treatment. The main objective of the study is to identify neurophysiological indicators of effectiveness of Mindfulness treatment in patients with migraine without high-frequency aura with clinically available devices (MEG and hdEEG). Another goal is to recognize the indicators also in the signal acquired with wearable devices in home use (wEEG). Finally, another goal will be to study the relationship between the identified neurophysiological markers and the change in neuropsychological test scores.",[55,56,29],"Migraine","Migraine Disease",[55,58,59,60],"MEG","Mindfulness","Wearable EEG","2025-04-14",{"date":63,"type":34},"2025-04-22",{"date":65,"type":34},"2024-04-23",{"date":67,"type":22},"2026-06",{"name":69,"class":70},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",1]