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CompletedNCT04439656Updated Jul 5, 2022

Detecting Absence Seizures Using Eye Tracking

An observational study in Epilepsy, Generalized, Absence Epilepsy and Absence Seizures, sponsored by Rachel Kuperman. Completed at 5 sites in United States. Open to participants aged 4 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by Rachel Kuperman · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
150
Ages
4 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epilepsy, Generalized
  • Absence Epilepsy
  • Absence Seizures
  • Seizures
  • Seizure Disorder

Keywords

  • eye movements
  • seizure detection
03

Who can participate

Ages eligible
4 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children or adults with absence seizures.

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

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
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Absence Seizures

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

    Diagnostic Test: Eye movement analysis

Interventions

  • Diagnostic testEye movement analysis

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

05

What researchers measure

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

    Time frame: 1 hour

06

Study locations

5 sites
  • Children's Hospital Orange County
    Orange, California 92868, United States
  • Rady Children's Hospital, San Diego
    San Diego, California 92123, United States
  • University of California, San Francisco
    San Francisco, California 94158, United States
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
  • Texas Child Neurology
    Plano, Texas 75024, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04439656
Lead sponsor
Rachel Kuperman
Collaborators
Children's Hospital of Orange County, University of California, San Francisco, Wake Forest University Health Sciences
Responsible party
Rachel Kuperman (Director, Clinical Research, Eysz, Inc.) — Sponsor-investigator
First posted
Jun 19, 2020
Start date
Jul 15, 2020
Primary completion
Jun 28, 2022
Completion
Jun 28, 2022
Last update
Jul 5, 2022

Study contacts

Rachel Kuperman, MD
principal investigator · Eysz, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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