Epilepsy and first unprovoked seizure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Children and adolescents with epilepsy or a first unprovoked epileptic seizure - Healthy children and adolescents (control group) - Written informed consent from legal guardians as well as assent/consent from participants according to age and capacity to understand
Exclusion criteria
Exclusion criteria: - Insufficient ability to cooperate or inability to complete the assessment as judged by the investigators - Insufficient German language proficiency - Known tonic or atonic drop seizures (clinical cohort only; safety aspect related to the eye-tracking device) - Neurological disorders or chronic diseases involving the central nervous system (healthy control group only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Objective assessment of cognitive changes, particularly executive functions, using eye-tracking parameters and derived measures during the EpiTrack Junior assessment. Recorded parameters include eye movement patterns (e.g., fixation duration, saccade frequency), pupil diameter, gaze shifts, reaction times to visual stimuli/tasks, and problem-solving behavior (number and type of errors/solutions). Timepoint(s) of assessment: For participants with epilepsy and healthy controls, assessments are performed once at study inclusion. For the cohort with a first unprovoked epileptic seizure, assessments are performed at baseline and repeated after 8–12 weeks. Method of data collection: Data are collected during administration of the EpiTrack Junior neuropsychological screening test in combination with an eye-tracking device (Pupil Labs Neo glasses). Clinical and demographic data are additionally obtained from medical records and participant/parent interviews. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: Assessment of potential associations between eye-tracking parameters and the results of selected subtests of the EpiTrack Junior. In addition, correlation coefficients, prediction accuracy, precision, sensitivity, and potential classifications will be analyzed. Timepoint(s) of assessment: For children and adolescents with epilepsy and healthy controls, assessments are performed once at study inclusion. For the cohort with a first unprovoked epileptic seizure, assessments are performed at baseline and repeated after 8–12 weeks. Method of data collection: Data are collected during administration of the EpiTrack Junior neuropsychological screening test in combination with an eye-tracking device (Pupil Labs Neo). Secondary endpoints are determined through statistical analyses of the recorded eye-tracking data and the corresponding EpiTrack Junior subtest results. | — |
Countries
Germany
Contacts
Universitätsklinikum Bonn – Zentrum für Kinder- und Jugendmedizin, Abteilung Neuropädiatrie/SPZ