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OpenTrials
Completed

NCT Number: NCT03745118

Development of a Practical, Minimally Invasive Seizure Gauge

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

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

EpiTel EpiLog

Device

Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel

Other names: Epilog

Byte Flies Sensor Dots

Device

Plastic pads that will be adhered to your chest area

Other names: Byteflies, Sensor Dots

Empatica E4

Device

wearable seizure detection wristband

Other names: E4 Wristband

Biovotion Everion

Device

wearable seizure detection device armband that is attached to upper arm

GENEactiv

Device

wearable seizure detection watch

Primary outcomes

  1. Assessment of Physiological Signals Measurable with Wearable Sensors

    Time frame: 2-10 days approximately

    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. Pattern Analysis

    Time frame: 2-10 days approximately

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 19, 2018
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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