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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04439656
Other study ID # DASEY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date June 28, 2022

Study information

Verified date June 2022
Source Eysz, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 28, 2022
Est. primary completion date June 28, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 100 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Eye movement analysis
Eye movements will be analyzed to identify if seizures are present and compared to the EEG read

Locations

Country Name City State
United States Children's Hospital Orange County Orange California
United States Texas Child Neurology Plano Texas
United States Rady Children's Hospital, San Diego San Diego California
United States University of California, San Francisco San Francisco California
United States Wake Forest Baptist Health Winston-Salem North Carolina

Sponsors (4)

Lead Sponsor Collaborator
Rachel Kuperman Children's Hospital of Orange County, University of California, San Francisco, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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