Assessing Comorbidities in Epilepsy Using Eye Movement Recordings

NCT06310772 | Completed

• 1 other identifier: NSF 2304297
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Childhood Absence Epilepsy; Absence Seizures; Epilepsy Comorbidities

Keywords

absence epilepsy

Outcome Measures

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.

  1 year

Secondary Outcomes (1)

• Eye Movements to Diagnose Attention challenges

  1 year

Study Arms (1)

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

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eysz, Inc.: lead
• Wake Forest University Health Sciences: collaborator
• Children's Hospital of Orange County: collaborator
• University of Colorado, Denver: collaborator

Study Sites (2)

Children's Hospital Orange County

Orange, California, 92868, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Epilepsy, Absence; Seizures

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 15, 2024
• Study Start: April 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)