{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T17:27:32Z","timestamp":1793294852799,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2025,9]]},"abstract":"Abstract<\/jats:title>Objective<\/jats:title>Patient self\u2010report is known to be an inaccurate reflection of true seizure frequency in persons with epilepsy. The current study aimed to assess the safety and performance of the Minder system, a bilateral subscalp electroencephalographic (EEG) acquisition system for continuous long\u2010term EEG recording.<\/jats:p><\/jats:sec>Methods<\/jats:title>This prospective, multicenter first\u2010in\u2010human study enrolled adult patients with focal or generalized epilepsy and at least two seizures per month. The primary outcome was adverse events (AEs) in the first 6\u2009months of implantation. Secondary analyses determined whether normal neurophysiological signals, interictal discharges, and seizures seen on scalp video\u2010EEG monitoring were identifiable on subscalp recordings, and signals were rated for clarity on subscalp and two\u2010channel scalp EEG recordings (1\u2009=\u2009not recognizable, 5\u2009=\u2009clear). Subscalp data were reviewed in relation to events reported in 6\u2010month seizures diaries.<\/jats:p><\/jats:sec>Results<\/jats:title>Twenty\u2010six subjects were implanted between November 2019 and July 2023. No serious device\u2010 or implant procedure\u2010related AEs were reported. The most common device\u2010related AEs were mild or moderate postsurgical pain, headache, or scalp pain\/paresthesia (9\/26, 35%). All sleep spindles, chewing artifacts, interictal discharges, and electrographic seizures observed on scalp recordings (25 seizures from eight patients) were identified on subscalp recordings and given higher clarity ratings compared to two\u2010channel scalp recordings (median seizure clarity rating was 3 for both scalp and subscalp EEG, range\u2009=\u20091\u20135, p<\/jats:italic>\u2009=\u2009.0025). Subscalp recordings captured seizures from diverse seizure focus locations, including frontal and mesial temporal seizure foci and hypothalamic hamartoma. Bilateral recording revealed clinically relevant findings not possible with unilateral recordings (6\/26 patients, 23%). Findings of potential clinical utility were identified on manual review of 6\u2010month recordings in most patients (23\/26, 88%).<\/jats:p><\/jats:sec>Significance<\/jats:title>This study demonstrates the safety and performance of the Minder bilateral subscalp EEG acquisition system for long\u2010term seizure monitoring in patients with epilepsy. Bilateral hemisphere coverage captured seizures in a diverse patient group and permitted lateralization of events.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.18458","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T10:49:43Z","timestamp":1748602183000},"page":"3426-3439","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["The UMPIRE study: A first\u2010in\u2010human multicenter trial of bilateral subscalp monitoring for epileptic seizure detection"],"prefix":"10.1111","volume":"66","author":[{"given":"Amy J.","family":"Halliday","sequence":"first","affiliation":[{"name":"Department of Clinical Neurosciences St Vincent's Hospital Melbourne Melbourne Victoria Australia"},{"name":"Department of Medicine St Vincent's Hospital Melbourne, University of Melbourne Melbourne Victoria 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for Advanced Medicine University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taneeta M.","family":"Ganguly","sequence":"additional","affiliation":[{"name":"Penn Neuroscience Center\u2013Neurology, Perelman Center for Advanced Medicine University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"Ellis","sequence":"additional","affiliation":[{"name":"Penn Neuroscience Center\u2013Neurology, Perelman Center for Advanced Medicine University of Pennsylvania Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin C.","family":"Conrad","sequence":"additional","affiliation":[{"name":"Penn Neuroscience Center\u2013Neurology, Perelman Center for Advanced Medicine University of Pennsylvania Philadelphia Pennsylvania 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