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CompletedNCT06310772ACERUpdated Oct 15, 2025

Assessing Comorbidities in Epilepsy Using Eye Movement Recordings

An observational study in Childhood Absence Epilepsy, Absence Seizures and Epilepsy Comorbidities, sponsored by Eysz, Inc.. Completed at 2 sites in United States. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-15.

Sponsored by Eysz, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
4 Years to 12 Years
Sex
All
01

Study summary

This study wants to make it easier to find kids with a type of epilepsy called childhood absence epilepsy (CAE) who might have problems with ongoing seizures and thinking. Right now, doctors use tests that can be expensive and take a long time. Eysz is developing a system that looks at how kids move their eyes which might help find CAE more quickly and accurately. This study will compare Eysz with the usual tests to see if it can predict seizures and thinking problems in kids with CAE. The goal is to find these problems earlier and help kids do better in school and life.

Read the detailed description

This study addresses the challenges in managing childhood absence epilepsy (CAE), a condition that poses risks of injury and cognitive issues despite normal intelligence levels. Current management relies heavily on subjective reporting and costly, time-consuming tests such as neuropsychiatric assessments and EEGs. However, these methods often underestimate seizure burden and neurocognitive comorbidities, leading to missed opportunities for early intervention. Eysz, a novel system analyzing eye movements, has shown promise in identifying CAE features through passive analysis. Building upon this, the study aims to validate Eysz against established tests like EEGs and questionnaires to develop a rapid and objective tool for identifying CAE in children at risk of poor outcomes due to ongoing seizures or cognitive issues. By evaluating eye-movement features in comparison with hyperventilation, EEG results, and various assessments, the goal is to enable earlier diagnosis, quicker attainment of seizure freedom, and identification of at-risk children who may benefit from interventions to improve cognitive outcomes during critical developmental periods.

The study will assess features such as saccade frequency, fixation duration, and eye blink frequency measured by the Eysz system and correlate them with clinical outcomes. By improving the accuracy and efficiency of CAE diagnosis, the study aims to reduce the burden on patients and caregivers while enhancing overall treatment outcomes. Additionally, the findings may contribute to a better understanding of the relationship between eye movements and neurological conditions, potentially opening avenues for future research and intervention strategies. Through collaboration with clinicians and researchers, this study seeks to address the unmet needs in CAE management and ultimately improve the quality of life for affected children and their families.

02

Conditions studied

  • Childhood Absence Epilepsy
  • Absence Seizures
  • Epilepsy Comorbidities

Keywords

  • absence epilepsy
03

In context

Epilepsy, Absence

27 studies on the registry are indexed under Epilepsy, Absence; 2 are open to participants now.

Browse Epilepsy, Absence studies →

Lead sponsor

Eysz, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

A diverse group of children (4-12 years) with childhood absence epilepsy (CAE) and healthy controls will be recruited from epilepsy centers in North Carolina, California, and Colorado. Inclusion criteria involve confirmed CAE diagnosis or healthy controls, absence of other neurological disorders, and various socio-economic backgrounds. Exclusion criteria include conditions or medications affecting eye movements or cognition.

Inclusion criteria

Diagnosis of Childhood Absence Epilepsy by Treating Neurologist or a Healthy control Fluent in English

Exclusion criteria

Exclusion Criteria:

History of subarachnoid hemorrhage, sickle cell anemia, recent cerebrovascular accident or myocardial infarction, significant cardiopulmonary disease, active asthma, known aneurysm, known moyamoya disease, or pregnancy.

Known diagnosis of strabismus or amblyopia Any vision abnormalities that prevent the participant from viewing the screen clearly People who have a history of generalized tonic clonic convulsions To participate as a healthy control the participant must have no personal history of epilepsy, ADHD or other developmental disorder, no first degree relatives with the above diagnosis

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Children with CAE or Controls

    Pediatric Epilepsy Side Effect Questionnaire Continuous Performance Test Children's Sleep Questionnaire Anxiety/Depression Screening Eye tracking during active tasks- saccade/antisaccade task, and passive tasks

06

What researchers measure

Primary outcomes

  1. Eye Movements to Diagnose CAE

    Use machine learning algorithms based on eye movement feature analysis (e.g., saccade frequency and velocity, fixation duration, and eye blink frequency) to identify people with CAE, and those with ongoing seizure activity with \> 75% sensitivity and specificity.

    Time frame: 1 year

Secondary outcomes

  1. Eye Movements to Diagnose Attention challenges

    Use machine learning algorithms based on eye movement feature analysis to identify people with epilepsy whose CPT score indicates attention deficits and those with PESQ score \> 34 (1 standard deviation from mean) with \> 75% sensitivity and specificity.

    Time frame: 1 year

07

Study locations

2 sites
  • Children's Hospital Orange County
    Orange, California 92868, United States
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06310772
Lead sponsor
Eysz, Inc.
Collaborators
Wake Forest University Health Sciences, Children's Hospital of Orange County, University of Colorado, Denver
Responsible party
Rachel Kuperman (CEO, Eysz, Inc.) — Principal investigator
First posted
Mar 15, 2024
Start date
Apr 15, 2024
Primary completion
Jul 1, 2025
Completion
Oct 1, 2025
Last update
Oct 15, 2025

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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