Development of a Minimally Invasive Seizure Gauge

NCT ID: NCT03882671

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-31

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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Monitoring Device

Subjects will be asked to wear up to 3 different noninvasive seizure detection devices including EpiTel EpiLog, Empatica E4, GeneActiv

Group Type EXPERIMENTAL

EpiTel Epilog

Intervention Type DEVICE

EEG recording device

Empatica E4

Intervention Type DEVICE

PPG, sweat level, temperature and accelerometry recording device

GENEActiv

Intervention Type DEVICE

Temperature, light level and accelerometry recording device

Interventions

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EpiTel Epilog

EEG recording device

Intervention Type DEVICE

Empatica E4

PPG, sweat level, temperature and accelerometry recording device

Intervention Type DEVICE

GENEActiv

Temperature, light level and accelerometry recording device

Intervention Type DEVICE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seer Medical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean R Freestone, PhD BEng

Role: PRINCIPAL_INVESTIGATOR

CEO

Locations

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Seer Medical

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC042_18

Identifier Type: -

Identifier Source: org_study_id

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