Clinical trial NCT06836687: Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure
Official title: Monocentric Study to Investigate the Effect of the New Definition of Epilepsies of the International League Against Epilepsy of 2014 on the Diagnosis After the First Seizure, on Patient Satisfaction, Cognition and Health Economic Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Seizure, Epileptic
Neuropsychology
Outcome
Keywords: First epileptic seizure
Definition of epilepsy
Neuropsychology
outcome
Lead sponsor: University Hospital Marburg
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with an nunprovoked epileptic seizure

Brief summary: The present study is a prospective study on the development of seizure frequency, medication adherence, quality of life and cognitive performance after a first epileptic seizure using the new diagnostic criteria for epilepsy of the International League Against Epilepsy of 2014 at the time of diagnosis.

Detailed description: The new diagnostic criteria for epilepsy, which have been in place since 2014, suggest that due to the improved possibilities for early diagnosis and treatment - particularly as a result of improved imaging diagnostics - changes in the incidence rates and severity of the course of epilepsies with different etiologies can be expected.

The group of epilepsies with unclear etiology should now be smaller than in previous studies. The MRI- and EEG-positive patients can now be identified as having structural epilepsy based on the type of lesion, which was not possible in previous studies without differentiated imaging. The fact that these patients can now be treated before a patients can now be treated before a second seizure, the risk of recurrence and the health economic costs should also be reduced and have a positive effect on maintaining cognitive performance and quality of life after a first epileptic seizure.

The aim of the study is to record the consequences of the new epilepsy diagnostic criteria in terms of outcome and treatment. In addition, the investigators will use a questionnaire battery and neuropsychological testing to record the potential neuropsychological deficits, financial and socio-medical consequences of a first seizure or early-stage epilepsy.

Eligibility criteria: Inclusion Criteria:

* Completion of the 18th year of life
* first epileptic seizure
* Ability to understand the patient information and to give written consent
* Written consent for voluntary participation in the study

Exclusion Criteria:

* Chronic drug or alcohol abuse in the last two years

Primary outcomes:
measure: Rate of seizure recurrency
timeFrame: 10 Years
Secondary outcomes:
measure: employment
timeFrame: 10 years
measure: Salary
timeFrame: 10 years
measure: Driving restriction
timeFrame: 10 Years
measure: Verbale Lern- und Merkfähigkeitstest
timeFrame: 10 years
measure: Regensburger Wortflüssigkeits-Test
timeFrame: 10 Years
measure: Copy and recall of the Rey-Osterrieth Figure
timeFrame: 10 Years
measure: Trailmaking Test A & B
timeFrame: 10 Years
measure: Wechsler Adult Intelligence Scale - WAIS IV
timeFrame: 10 Years
measure: TAP
timeFrame: 10 Years
measure: Relationsship status
timeFrame: 10 years
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: c/o Klinik für Neurologie
state: Hessen
Study officials:
References: