[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616110":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":38,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"Precisis US, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.",[13],"Device: Implantable minimaly invasive brain stimulator",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Implantable minimaly invasive brain stimulator","Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months.",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Perry Rice","CONTACT","+49 6221 6559321","p.rice@precisis.de",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Aude Yulzari","a.yulzari@precisis.de",{"type":39,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100616110","easee-system-pivotal-study-for-the-united-states-of-america-100616110",false,"NCT07301346","EASEE® System Pivotal Study for the United States of America","EASEE4US","Inclusion Criteria:\n\n* Adult between 18-75 years of age\n* Diagnosis of drug-resistant focal epilepsy\n* At least four (4) observable seizure manifestations per month\n* Stable anti-seizure medication regimen\n\nExclusion Criteria:\n\n* Diagnostic of non-epileptic seizures\n* Active idiopathic generalized epilepsy\n* Recent status epileptics (\\\u003C12 months)\n* Clinically significant or unstable medical condition\n* Active psychosis, major depression, suicidal ideation (\\\u003C6 months)\n* Pregnancy\n* Implanted with brain stimulation device or active Vagus Nerve Stimulation","ALL","18 Years","75 Years",{"count":51,"type":52},200,"ESTIMATED","INTERVENTIONAL",[55],"NA","The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:\n\n1. Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?\n2. Is the use of EASEE(R) System safe after up to 28 and up to 84 days?\n\nParticipants will be asked to:\n\n* Complete a seizure diary for the duration of the clinical trial\n* Attend study visits for 20 months of their clinical trial participation\n* Undergo EASEE(R) System implant\n* Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)\n* Receive neurostimulation for at least 12 months",[58],"Drug-Resistant Focal Epilepsy",[60,61,62,63,64],"EASEE System","Precisis","Neurostimulation","Epilepsy","Focal Cortex Stimulation","NOT_YET_RECRUITING","2026-04-27",{"date":68,"type":69},"2026-05-01","ACTUAL",{"date":71,"type":52},"2026-07-01",{"date":73,"type":52},"2030-07-01",{"name":5,"class":6}]