Development of a Practical, Minimally Invasive Seizure Gauge

Mayo Clinic

Status: Completed

Conditions: Epilepsy

Treatments: Device: EpiTel EpiLog; Device: Empatica E4; Device: Byte Flies Sensor Dots; Device: Biovotion Everion; Device: GeneActiv

Study type: Interventional

Funder types: Other

Identifiers

NCT03745118

18-008357

Details and patient eligibility

About

The researchers are trying to assess changes in physiological signals before and during seizures.

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Monitoring Device

Other group

Description:

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

Treatment:

Device: Byte Flies Sensor Dots

Device: Empatica E4

Device: Biovotion Everion

Device: EpiTel EpiLog

Device: GeneActiv