Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310772
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-02-27
Brief Title:
Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
Sponsor:
Eysz Inc
Organization:
Eysz Inc
Study Overview
Official Title:
Assessing Comorbidities in Epilepsy Using Eye Movement Recordings
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACER
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None