Childhood Absence EpilepsyACERNCT06310772
Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
An observational study of Childhood Absence Epilepsy and Absence Seizures, run by Eysz, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Absence Epilepsy, Absence Seizures, Epilepsy Comorbidities
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Diagnosis of Childhood Absence Epilepsy by Treating Neurologist or a Healthy control Fluent in English
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Orange County
Orange, California, 92868
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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.
- Keywords
- absence epilepsy
- Medical subject headings
- Epilepsy, Absence, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Apr 2024
- Primary completion1 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eysz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences, Children's Hospital of Orange County, University of Colorado, Denver
- Responsible party
- Principal investigator, Rachel Kuperman, Eysz, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310772
- Sponsor's protocol ID
- NSF 2304297
- Acronym
- ACER
- Status last verified
- Oct 2025
- First submitted
- 27 Feb 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
- ClinicalTrials.gov ID
- NCT06310772
- Acronym / sponsor ID
- ACER / NSF 2304297
- Keywords
- absence epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eysz, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences, Children's Hospital of Orange County, University of Colorado, Denver
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of Childhood Absence Epilepsy by Treating Neurologist or a Healthy control Fluent in English
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Eye Movements to Diagnose CAE
Time frame: 1 year
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 secondary outcome
Eye Movements to Diagnose Attention challenges
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Absence Epilepsy and Absence Seizures, run by Eysz, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye Movements to Diagnose CAE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.