Optimizing Pharmacotherapy with Noninvasive Wearable Sensors and Subscalp EEG

利用无创可穿戴传感器和头皮下脑电图优化药物治疗

• 批准号: 10286466
• 负责人: Benjamin H Brinkmann
• 金额: $ 60.49万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-04 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10286466
• 关键词: Affect; Automobile Driving; Behavioral; Benzodiazepines; Biological Markers; Chronic; Clinical; Data; Detection; Devices; Disease; Dose; Electrodes; Electroencephalography; Electrophysiology (science); Environment; Epilepsy; Event; FDA approved; Feasibility Studies; Goals; Heart Rate; Hemorrhage; Hospitals; Implant; Incidence; International; Investigation; Medical; Methods; Monitor; Motor Seizures; Nature; Patient Monitoring; Patient Recruitments; Patients; Pattern; Periodicity; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Physiological; Probability; Process; Publishing; Quality of life; Reporting; Research; Risk; Scalp structure; Seizures; Self Administration; Signal Transduction; Surrogate Markers; System; Telemetry; Testing; Time; Vendor; Work; Wrist; algorithm development; algorithm training; base; cohort; convolutional neural network; data acquisition; data streams; empowerment; experience; feasibility trial; handheld equipment; infection risk; innovation; machine learning method; novel; prevent; prospective; safety and feasibility; safety study; sensor; side effect; targeted treatment; usability; wearable device; wearable sensor technology

Project Summary The apparently random nature of seizures is one of the most significant factors affecting quality of life for patients with epilepsy. Accurate seizure forecasting could be transformative for patients with epilepsy, allowing patients to modify activities to avoid risk, take fast-acting medications to stop seizures before they develop, and provide a sense of empowerment over their disease. Successful seizure prediction has now been established using ambulatory intracranial EEG devices. Unfortunately, no such device is currently available to patients, as no commercial vendor has been successful to date at obtaining approval for clinical use of such a device. Furthermore, invasive intracranial implants may not be appropriate for or acceptable to many patients given the associated risk of infection and hemorrhage. Subscalp EEG recording has recently emerged as a viable means for long-term monitoring of patients with epilepsy. A device is commercially available in the EU, but does not yet have FDA clearance in the US. Recently published studies show the device to be reliable and robust, and recordings longer than 6 months have been reported. In addition cycles of seizure risk have been identified in wearable device physiological signals, and these long-term cycles may be capable of contributing to the accuracy of seizure forecasts. This project will develop the ability to prospectively forecast seizures from simultaneous subscalp EEG and wrist-worn wearable signals, and will assess the safety and feasibility of administering a fast-acting supplemental medication with seizure forecasts to prevent seizures.

项目概要 癫痫发作明显的随机性是影响患者生活质量的最重要因素之一 患有癫痫。准确的癫痫发作预测可能会给癫痫患者带来变革，让患者能够 调整活动以避免风险，服用速效药物在癫痫发作之前阻止癫痫发作，并提供 对疾病的赋权感。现在已经使用以下方法建立了成功的癫痫发作预测 动态颅内脑电图设备。不幸的是，目前患者还没有这样的设备，因为没有 迄今为止，商业供应商已成功获得此类设备临床使用的批准。 此外，鉴于以下原因，侵入性颅内植入物可能不适合或不为许多患者所接受。 感染和出血的相关风险。头皮下脑电图记录最近已成为一种可行的手段 用于对癫痫患者进行长期监测。设备已在欧盟上市，但并未上市 尚未在美国获得 FDA 许可。最近发表的研究表明该设备可靠且坚固，并且 据报道，录音时间超过 6 个月。此外，癫痫发作风险的周期已在 可穿戴设备的生理信号，这些长期周期可能有助于 癫痫发作预测的准确性。该项目将开发前瞻性预测缉获量的能力 同时进行头皮下脑电图和腕戴式可穿戴信号，并将评估其安全性和可行性 给予速效补充药物并预测癫痫发作以预防癫痫发作。