Ear-Seizure Detection (EarSD) Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Ear-SD, Electroencephalogram.
- Кому может быть актуально
- Состояния в реестре: Seizures, Epilepsy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System
Обзор
The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.
Подробное описание
A wearable seizure detection and prediction device (EarSD) is worn by patients with epileptic seizures. In this study, the goal is to validate the accuracy of a newly developed portable seizure detection device by examining if the Ear-SD device can (1) provide more comfort, (2) be unobtrusive to the subject during daily activities, and (3) be able to provide additional insight on a patients' seizure control.
Вмешательства
- Устройство Ear-SD
The Ear-SD is a purely EEG recording device Continuous Electroencephalogram (cEEG), Electromyogram (EMG), Electrooculogram (EOG), Photoplethysmogram (PPG), Electrodermoactivity (EDA), and Inertial Measurement Unit (IMU). The Ear-SD device rests on the ears and connects to the scalp by two sticker electrodes. - Диагностический тест Electroencephalogram
Standard 21-channel scalp-continuous electroencephalogram (cEEG) with video recording and electrocardiogram (ECG)
Первичные конечные точки
- Seizure Recording Criteria 1 [Срок оценки: Through study completion, an average of 7 Days]
- Seizure Recording Criteria 2 [Срок оценки: Through study completion, an average of 7 Days]
- Seizure Recording Criteria 3 [Срок оценки: Through study completion, an average of 7 Days]
- Data Interpretation [Срок оценки: up to 2 years]
- Seizure Accuracy/Prediction [Срок оценки: up to 5 years]
Вторичные конечные точки (1)
- Qualitative Satisfaction Survey [Срок оценки: Through study completion, an average of 7 Days]
Критерии участия
Критерии включения
- Age ≥ 18 years.
- Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy.
- Willing to wear the wearable device.
- Ability to provide informed consent
Критерии исключения
- Subjects wearing other ear devices such as hearing aids.
- Inability or unwillingness to provide informed consent.
- Irritation of the skin where the device is to be placed.
- Patients with intracranial electrodes placement.
- Prisoners
- Cognitive impaired individuals
- Pregnant Women
- Children (Age 0-17)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
США · 2 центра
- Ummmc-Memorial Campus — Worcester
- Ummmc-University Campus — Worcester
Публикации
- Barranco R, Caputo F, Molinelli A, Ventura F. Review on post-mortem diagnosis in suspected SUDEP: Currently still a difficult task for Forensic Pathologists. J Forensic Leg Med. 2020 Feb;70:101920. doi: 10.1016/j.jflm.2020.101920. Epub 2020 Feb 5. PMID 32090969
- Blachut B, Hoppe C, Surges R, Elger C, Helmstaedter C. Subjective seizure counts by epilepsy clinical drug trial participants are not reliable. Epilepsy Behav. 2017 Feb;67:122-127. doi: 10.1016/j.yebeh.2016.10.036. Epub 2017 Jan 28. PMID 28139449
- Prior PF, Virden RS, Maynard DE. An EEG device for monitoring seizure discharges. Epilepsia. 1973 Dec;14(4):367-72. doi: 10.1111/j.1528-1157.1973.tb03975.x. No abstract available. PMID 4521092
- Manabe, H., Fukumoto, M., & Yagi, T. (2015a). Conductive rubber electrodes for earphone-based eye gesture input interface. Personal and Ubiquitous Computing, 19(1), 143-154. doi:10.1007/s00779-014-0818-8
- A. H. Shoeb and J. Guttag, "Application of Machine Learning To Epileptic Seizure Detection," in 2010 International Conference on Machine Learning (ICML), Jun. 2010. [Online]. Available: https://www.semanticscholar.org/paper/Application-of-Machine-Learning-ToEpileptic-Shoeb-Guttag/57e4afe9ca74414fa02f2e0a929b64dc9a03334d.
- Zandi AS, Javidan M, Dumont GA, Tafreshi R. Automated real-time epileptic seizure detection in scalp EEG recordings using an algorithm based on wavelet packet transform. IEEE Trans Biomed Eng. 2010 Jul;57(7):1639-51. doi: 10.1109/TBME.2010.2046417. PMID 20659825
- Doyle OM, Temko A, Marnane W, Lightbody G, Boylan GB. Heart rate based automatic seizure detection in the newborn. Med Eng Phys. 2010 Oct;32(8):829-39. doi: 10.1016/j.medengphy.2010.05.010. Epub 2010 Jul 1. PMID 20594899
- Jansen K, Varon C, Van Huffel S, Lagae L. Peri-ictal ECG changes in childhood epilepsy: implications for detection systems. Epilepsy Behav. 2013 Oct;29(1):72-6. doi: 10.1016/j.yebeh.2013.06.030. Epub 2013 Aug 10. PMID 23939031
Идентификаторы
NCT: NCT06598189 · STUDY00001889