Detecting Absence Seizures Using Eye Tracking

NCT04439656 | Completed FDA Device

• 1 other identifier: DASEY
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Epilepsy, Generalized; Absence Epilepsy; Absence Seizures; Seizures; Seizure Disorder

Keywords

eye movements; seizure detection

Outcome Measures

Primary Outcomes (1)

• Eysz algorithm to detect absence seizures

  EEG is burdensome and limited. The current accepted method of counting seizures is observation which fails to identify \> 50% of seizures. The goal is to validate the Eysz absence seizure detection algorithm and show significant improvement over current standard of care

  1 hour

Study Arms (1)

Absence Seizures

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

Diagnostic Test: Eye movement analysis

Interventions

Eye movement analysis DIAGNOSTIC_TEST

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

Absence Seizures

Eligibility Criteria

• Age: 4 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children or adults with absence seizures.

You may qualify if:

• Provision of signed and dated informed consent form- per local IRB
• Stated willingness to comply with all study procedures including the clicker test and availability for the duration of the study
• Male or female, aged 4-100
• 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
• Scheduled for clinical EEG observation

You may not qualify if:

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

Sponsors & Collaborators

• Rachel Kuperman: lead
• Children's Hospital of Orange County: collaborator
• University of California, San Francisco: collaborator
• Wake Forest University Health Sciences: collaborator

Study Sites (5)

Children's Hospital Orange County

Orange, California, 92868, United States

Location

Rady Children's Hospital, San Diego

San Diego, California, 92123, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Texas Child Neurology

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Epilepsy, Generalized; Epilepsy, Absence; Seizures; Epilepsy

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Rachel Kuperman, MD

  Eysz, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 19, 2020
• Study Start: July 15, 2020
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)