Detecting Absence Seizures Using Eye Tracking

• ClinicalTrials.gov Identifier: NCT04439656
• Recruitment Status: Completed
• First Posted: June 19, 2020
• Last Update Posted: July 4, 2022
• Sponsor: Rachel Kuperman
• Collaborators: Children's Hospital of Orange County; University of California, San Francisco; Wake Forest University Health Sciences
• Information provided by (Responsible Party): Rachel Kuperman, Eysz, Inc.

Study Description

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.

Condition or disease	Intervention/treatment
Epilepsy, Generalized; Absence Epilepsy; Absence Seizures; Seizures; Seizure Disorder	Diagnostic Test: Eye movement analysis

Detailed Description:

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Detecting Absence Seizures Using Eye Tracking
• Actual Study Start Date: July 15, 2020
• Actual Primary Completion Date: June 28, 2022
• Actual Study Completion Date: June 28, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Absence Seizures; Participants with absence seizures will have their eye movements compared to the EEG recording.	Diagnostic Test: Eye movement analysis; Eye movements will be analyzed to identify if seizures are present and compared to the EEG read

Outcome Measures

Primary Outcome Measures :

1. Eysz algorithm to detect absence seizures [ Time Frame: 1 hour ]
   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

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 100 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children or adults with absence seizures.

Criteria

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

Contacts and Locations

Locations

United States, California

Children's Hospital Orange County

Orange, California, United States, 92868

Rady Children's Hospital, San Diego

San Diego, California, United States, 92123

University of California, San Francisco

San Francisco, California, United States, 94158

United States, North Carolina

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

United States, Texas

Texas Child Neurology

Plano, Texas, United States, 75024

Sponsors and Collaborators

Rachel Kuperman

Children's Hospital of Orange County

University of California, San Francisco

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Rachel Kuperman, MD; Eysz, Inc.

More Information

• Responsible Party: Rachel Kuperman, Director, Clinical Research, Eysz, Inc.
• ClinicalTrials.gov Identifier: NCT04439656
• Other Study ID Numbers: DASEY
• First Posted: June 19, 2020
• Last Update Posted: July 4, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Rachel Kuperman, Eysz, Inc.:

eye movements; seizure detection

Additional relevant MeSH terms:

Epilepsy; Seizures; Epilepsy, Absence; Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epileptic Syndromes