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OpenTrials
Completed

NCT Number: NCT03882671

Development of a Minimally Invasive Seizure Gauge

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seer Medical

Melbourne, Victoria, 3000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

EpiTel EpiLog

Device

EEG recording device

Empatica E4

Device

PPG, sweat level, temperature and accelerometry recording device

GENEactiv

Device

Temperature, light level and accelerometry recording device

Primary outcomes

  1. Multimodal Assessment of Physiological Signals During Seizure Events Measurable with Wearable Sensors

    Time frame: 2-7 days approximately

    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. Wearable Sensors Comfort Assessment

    Time frame: 2-7 days approximately

    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.

  3. Seizure Detection and Prediction using Multimodal Physiological Data

    Time frame: 2-7 days approximately

    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.

Sponsors and collaborators

Lead sponsor

Seer Medical Pty Ltd

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2019
Registry last updated
May 15, 2025

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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