Detail publikace

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

ATTIA, T. CREPEAU, D. KŘEMEN, V. NASSERI, M. GURAGAIN, H. STEELE, S. SLADKÝ, V. NEJEDLÝ, P. MÍVALT, F. HERRON, J. STEAD, M. DENISON, T. WORRELL, G. BRINKMANN, B.

Originální název

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

Typ

článek v časopise ve Web of Science, Jimp

Jazyk

angličtina

Originální abstrakt

Epilepsy 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.

Klíčová slova

epilepsy; deep brain stimulation; implantable devices; neuromodulation; seizure detection; seizure prediction; wearables

Autoři

ATTIA, T.; CREPEAU, D.; KŘEMEN, V.; NASSERI, M.; GURAGAIN, H.; STEELE, S.; SLADKÝ, V.; NEJEDLÝ, P.; MÍVALT, F.; HERRON, J.; STEAD, M.; DENISON, T.; WORRELL, G.; BRINKMANN, B.

Vydáno

29. 7. 2021

Nakladatel

Frontiers Media

Místo

LAUSANNE

ISSN

1664-2295

Periodikum

Frontiers in Neurology

Ročník

12

Číslo

1

Stát

Švýcarská konfederace

Strany od

1

Strany do

14

Strany počet

14

URL

Plný text v Digitální knihovně

BibTex

@article{BUT172423,
  author="Tal Pal {Attia} and Daniel {Crepeau} and Václav {Křemen} and Mona {Nasseri} and Hari {Guragain} and Steven W. {Steele} and Vladimír {Sladký} and Petr {Nejedlý} and Filip {Mívalt} and Jeffrey A. {Herron} and Matt {Stead} and Timothy {Denison} and Gregory {Worrell} and Benjamin H. {Brinkmann}",
  title="Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation",
  journal="Frontiers in Neurology",
  year="2021",
  volume="12",
  number="1",
  pages="1--14",
  doi="10.3389/fneur.2021.704170",
  issn="1664-2295",
  url="https://www.frontiersin.org/articles/10.3389/fneur.2021.704170/full"
}