Clinical trial NCT06310772: Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
Official title: Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Absence Epilepsy
Absence Seizures
Epilepsy Comorbidities
Keywords: absence epilepsy
Lead sponsor: Eysz, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
name: Children's Hospital of Orange County
name: University of Colorado, Denver
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eye Movements to Diagnose CAE
timeFrame: 1 year
Secondary outcomes:
measure: Eye Movements to Diagnose Attention challenges
timeFrame: 1 year
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
References: