Clinical trial NCT04439656: Detecting Absence Seizures Using Eye Tracking
Official title: Detecting Absence Seizures Using Eye Tracking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Generalized
Absence Epilepsy
Absence Seizures
Seizures
Seizure Disorder
Keywords: eye movements
seizure detection
Lead sponsor: Eysz, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Orange County
name: University of California, San Francisco
name: Wake Forest University Health Sciences
First posted: 2020-06-19
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children or adults with absence seizures.

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.

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.

Eligibility 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

Primary outcomes:
measure: Eysz algorithm to detect absence seizures
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital, San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Plano
country: United States
facility: Texas Child Neurology
state: Texas
Study officials:
affiliation: Eysz, Inc.
name: Rachel Kuperman, MD
role: PRINCIPAL_INVESTIGATOR
References: