Assessing Comorbidities in Epilepsy Using Eye Movement Recordings

NCT ID: NCT06310772

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Absence Epilepsy Absence Seizures Epilepsy Comorbidities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Children's Hospital of Orange County

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

Eysz, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Rachel Kuperman

CEO

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Orange County

Orange, California, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NSF 2304297

Identifier Type: -

Identifier Source: org_study_id

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