Detecting Absence Seizures Using Eye Tracking

NCT ID: NCT04439656

Last Updated: 2022-07-05

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

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-06-28

Brief Summary

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The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. Participants will wear an eye-tracker during a routine EEG.

Detailed Description

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Seizures can be difficult to detect outside of the hospital even with careful observation by a caregiver. EEG is the best method that we have to detect seizures- but it is uncomfortable for long term use outside of the hospital. The goal of this study is to develop a comfortable system that uses a wearable eye-tracker similar to eyeglasses to assist people with epilepsy in counting and measuring the severity of seizures. People participating in this study will have a routine EEG performed while an eye tracker measures eye movements. After the EEG is complete the researchers will compare the eye movements to the EEG to develop a software program that can detect seizures from eye movements.

Conditions

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Epilepsy, Generalized Absence Epilepsy Absence Seizures Seizures Seizure Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Absence Seizures

Participants with absence seizures will have their eye movements compared to the EEG recording.

Eye movement analysis

Intervention Type DIAGNOSTIC_TEST

Eye movements will be analyzed to identify if seizures are present and compared to the EEG read

Interventions

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Eye movement analysis

Eye movements will be analyzed to identify if seizures are present and compared to the EEG read

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent form- per local IRB
2. Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study
3. Male or female, aged 4-100
4. Experience known typical absence seizures as defined by the ILAE 2017 classification or referred to EEG lab for staring spell or concern for absence seizure

a. This will allow for inclusion of children and adults across the entire spectrum of disease states including new diagnosis (medication naive), medication responsive and non-medication responsive
5. Scheduled for clinical EEG observation

Exclusion Criteria

1. Intolerant of wearing or unable to wear the eyeglasses
2. Autism or other developmental disorder that the PI thinks will interfere with data collection
3. History of aggression that the PI thinks will interfere with data collection
4. History of not tolerating EEG that the PI thinks will interfere with data collection
5. Unable to give consent (for individuals ≥ 18 years old) unless they have an adult with power of attorney to consent
Minimum Eligible Age

4 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Orange County

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Rachel Kuperman

INDUSTRY

Sponsor Role lead

Responsible Party

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Rachel Kuperman

Director, Clinical Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rachel Kuperman, MD

Role: PRINCIPAL_INVESTIGATOR

Eysz, Inc.

Locations

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Children's Hospital Orange County

Orange, California, United States

Site Status

Rady Children's Hospital, San Diego

San Diego, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Texas Child Neurology

Plano, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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DASEY

Identifier Type: -

Identifier Source: org_study_id

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