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Clinical Trials/NCT04439656
NCT04439656
Completed
Not Applicable

Detecting Absence Seizures Using Eye Tracking

Rachel Kuperman5 sites in 1 country150 target enrollmentJuly 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy, Generalized
Sponsor
Rachel Kuperman
Enrollment
150
Locations
5
Primary Endpoint
Eysz algorithm to detect absence seizures
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
June 28, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Rachel Kuperman
Responsible Party
Sponsor Investigator
Principal Investigator

Rachel Kuperman

Director, Clinical Research

Eysz, Inc.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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
  • Scheduled for clinical EEG observation

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Study Sites (5)

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