Development of a Minimally Invasive Seizure Gauge

Study Overview
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Brief Summary
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The researchers are trying to assess changes in physiological signals before and during seizures.

Detailed Description
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Subjects that are undergoing video EEG monitoring in their home for their epilepsy at Seer Medical will be consented to participate in this study for a minimum of two days and/or the duration of their monitoring period for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys. When the subjects clinical EEG monitoring is completed data scientists will analyze the data to identify patterns.

Official Title
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Development of a Minimally Invasive Seizure Gauge

Conditions
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Epilepsy

Intervention / Treatment
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* Device: EpiTel Epilog
* Device: Empatica E4
* Device: GENEActiv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with epilepsy undergoing scalp EEG for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures Patients of age 18 or above Exclusion Criteria: Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring Device<br>Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv | Device: EpiTel Epilog<br>* EEG recording device<br>Device: Empatica E4<br>* PPG, sweat level, temperature and accelerometry recording device<br>Device: GENEActiv<br>* Temperature, light level and accelerometry recording device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors | We will collect physiological signals with the three wearable, noninvasive biosensors in Seer Medical patients undergoing scalp-recorded video EEG-ECG as part of their clinical epilepsy evaluation. These signals include temperature, light level, EEG, heart rate, galvanic skin response, PPG, accelerometry. We will evaluate biosignals based on reliability to detect seizures. | 2-7 days approximately | 
| Wearable Sensors Comfort Assessment | We will collect physiological signals with the three wearable, noninvasive biosensors in Seer Medical patients. We will evaluate subject comfort and ease of use for each device, measured through quantitative surveys. | 2-7 days approximately | 
| Seizure Detection and Prediction using Multimodal Physiological Data | We will apply data mining and machine learning methods to identify patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring. We will use sensitivity and specificity measures to determine which signals are most useful in detecting and predicting seizure events. | 2-7 days approximately |