Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation

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dc.contributor.authorAttia, Tal Palcs
dc.contributor.authorCrepeau, Danielcs
dc.contributor.authorKřemen, Václavcs
dc.contributor.authorNasseri, Monacs
dc.contributor.authorGuragain, Harics
dc.contributor.authorSteele, Steven W.cs
dc.contributor.authorSladký, Vladimírcs
dc.contributor.authorNejedlý, Petrcs
dc.contributor.authorMívalt, Filipcs
dc.contributor.authorHerron, Jeffrey A.cs
dc.contributor.authorStead, Mattcs
dc.contributor.authorDenison, Timothycs
dc.contributor.authorWorrell, Gregorycs
dc.contributor.authorBrinkmann, Benjamin H.cs
dc.coverage.issue1cs
dc.coverage.volume12cs
dc.date.accessioned2021-12-02T07:53:37Z
dc.date.available2021-12-02T07:53:37Z
dc.date.issued2021-07-29cs
dc.description.abstractEpilepsy is one of the most common neurological disorders, and it affects almost 1% of the population worldwide. Many people living with epilepsy continue to have seizures despite anti-epileptic medication therapy, surgical treatments, and neuromodulation therapy. The unpredictability of seizures is one of the most disabling aspects of epilepsy. Furthermore, epilepsy is associated with sleep, cognitive, and psychiatric comorbidities, which significantly impact the quality of life. Seizure predictions could potentially be used to adjust neuromodulation therapy to prevent the onset of a seizure and empower patients to avoid sensitive activities during high-risk periods. Long-term objective data is needed to provide a clearer view of brain electrical activity and an objective measure of the efficacy of therapeutic measures for optimal epilepsy care. While neuromodulation devices offer the potential for acquiring long-term data, available devices provide very little information regarding brain activity and therapy effectiveness. Also, seizure diaries kept by patients or caregivers are subjective and have been shown to be unreliable, in particular for patients with memory-impairing seizures. This paper describes the design, architecture, and development of the Mayo Epilepsy Personal Assistant Device (EPAD). The EPAD has bi-directional connectivity to the implanted investigational Medtronic Summit RC+S-TM device to implement intracranial EEG and physiological monitoring, processing, and control of the overall system and wearable devices streaming physiological time-series signals. In order to mitigate risk and comply with regulatory requirements, we developed a Quality Management System (QMS) to define the development process of the EPAD system, including Risk Analysis, Verification, Validation, and protocol mitigations. Extensive verification and validation testing were performed on thirteen canines and benchtop systems. The system is now under a first-in-human trial as part of the US FDA Investigational Device Exemption given in 2018 to study modulated responsive and predictive stimulation using the Mayo EPAD system and investigational Medtronic Summit RC+S-TM in ten patients with non-resectable dominant or bilateral mesial temporal lobe epilepsy. The EPAD system coupled with an implanted device capable of EEG telemetry represents a next-generation solution to optimizing neuromodulation therapy.en
dc.formattextcs
dc.format.extent1-14cs
dc.format.mimetypeapplication/pdfcs
dc.identifier.citationFrontiers in Neurology. 2021, vol. 12, issue 1, p. 1-14.en
dc.identifier.doi10.3389/fneur.2021.704170cs
dc.identifier.issn1664-2295cs
dc.identifier.other172423cs
dc.identifier.urihttp://hdl.handle.net/11012/203037
dc.language.isoencs
dc.publisherFrontiers Mediacs
dc.relation.ispartofFrontiers in Neurologycs
dc.relation.urihttps://www.frontiersin.org/articles/10.3389/fneur.2021.704170/fullcs
dc.rightsCreative Commons Attribution 4.0 Internationalcs
dc.rights.accessopenAccesscs
dc.rights.sherpahttp://www.sherpa.ac.uk/romeo/issn/1664-2295/cs
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/cs
dc.subjectepilepsyen
dc.subjectdeep brain stimulationen
dc.subjectimplantable devicesen
dc.subjectneuromodulationen
dc.subjectseizure detectionen
dc.subjectseizure predictionen
dc.subjectwearablesen
dc.titleEpilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulationen
dc.type.driverarticleen
dc.type.statusPeer-revieweden
dc.type.versionpublishedVersionen
sync.item.dbidVAV-172423en
sync.item.dbtypeVAVen
sync.item.insts2021.12.09 20:53:56en
sync.item.modts2021.12.09 20:14:15en
thesis.grantorVysoké učení technické v Brně. Fakulta elektrotechniky a komunikačních technologií. Ústav biomedicínského inženýrstvícs
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