Development of a Practical, 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 the hospital for their epilepsy at Mayo Clinic will be consented to participate in this study for a minimum of two days and/or the duration of their hospital stay for their clinical care. Subjects will be asked to wear up to 4 different commercially available seizure detection devices and complete surveys. In the second year of the study patients who have implanted devices capable of recording or detecting seizures will be recruited to wear a noninvasive biosensor for multiple months. This data will be used to develop algorithms capable of detecting and/or forecasting seizures. 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 Practical, Minimally Invasive Seizure Gauge

Conditions
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Epilepsy

Intervention / Treatment
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* Device: EpiTel EpiLog
* Device: Byte Flies Sensor Dots
* Device: Empatica E4
* Device: Biovotion Everion
* Device: GeneActiv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with epilepsy- scalp EEG or invasive EEG monitoring for clinical care, or an implanted device capable of monitoring brain activity and identifying seizures (e.g. NeuroPace RNS, Medtronic PC+S, Medtronic RC+S) Pediatric subjects 7 years of age or older. Exclusion Criteria: Cognitive or psychiatric condition rendering patient unable to cooperate with data collection, or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).

Ages Eligible for Study
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Minimum Age: 7 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 |
| --- | --- |
| Other: Monitoring Device<br>Subjects will be asked to wear up to 4 different noninvasive seizure detection devices including EpiTel EpiLog, Byte Flies Sensor Dots, Empatica E4, Biovotion Everion, GeneActiv | Device: EpiTel EpiLog<br>* Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel<br>* Other names: Epilog;Device: Byte Flies Sensor Dots<br>* Plastic pads that will be adhered to your chest area<br>* Other names: Sensor Dots;Device: Empatica E4<br>* wearable seizure detection wristband<br>* Other names: E4 Wristband;Device: Biovotion Everion<br>* wearable seizure detection device armband that is attached to upper arm<br>Device: GeneActiv<br>* wearable seizure detection watch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Physiological Signals Measurable with Wearable Sensors | We will collect physiological signals with the five wearable, noninvasive biosensors listed below in Mayo patients undergoing scalp-recorded video EEG and invasive stereotactic EEG/video monitoring as part of their clinical epilepsy evaluation. We will evaluate biosignals based on data quality and reliability, and subject comfort and ease of use. | 2-10 days approximately | 
| Pattern Analysis | We will apply data mining and machine learning methods to search for patterns in the collected physiological signals and correlate these patterns with the timing of seizures identified by the patient's clinical video-EEG monitoring. | 2-10 days approximately | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seizure