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Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06836687
Acronym
EFS-ILAE2014
Enrollment
1000
Registered
2025-02-20
Start date
2018-03-01
Completion date
2038-08-01
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropsychology, Outcome, Seizure, Epileptic

Keywords

First epileptic seizure, Definition of epilepsy, Neuropsychology, outcome

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.

Interventions

None listed

Sponsors

University Hospital Marburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of seizure recurrency10 YearsSeizure recurrency is recorded 6 months, 1 year, 3 years, 5 years and 10 years after the first seizure

Secondary

MeasureTime frameDescription
Salary10 yearsGross salary in Euro at the first attack, after 6 months, 1, 3, 5 and 10 years.
Driving restriction10 YearsFitness to drive (yes/no) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Verbale Lern- und Merkfähigkeitstest10 yearsVerbale Lern- und Merkfähigkeitstest - VLMT (Helmstaedter, Lendt, & Lux, 2001) at baseline and then after 1 years, 5 years and 10 years after the first seizure: 0 to 135 points, O worst, 135 best possible result.
Regensburger Wortflüssigkeits-Test10 YearsRegensburger Wortflüssigkeits-Test - RWT (Aschenbrenner, Tucha, & Lange, 2000) at baseline and then after 1 years, 5 years and 10 years after the first seizure: Number of words starting with one asked letter, that can be said in 2 minutes (typically between 0 and 50)
employment10 yearsCurrently working as employee or independent, retirement or long-time sick-leave at the first attack, after 6 months, 1, 3, 5 and 10 years.
Trailmaking Test A & B10 YearsTrailmaking Test A & B (Tombaugh, 2004) at baseline and then after 1 years, 5 years and 10 years after the first seizure: individual time to absolve the test in seconds
Wechsler Adult Intelligence Scale - WAIS IV10 YearsWechsler Adult Intelligence Scale - WAIS IV at baseline and then after 1 years, 5 years and 10 years after the first seizure: Intelligence quotient (40 to 160)
TAP10 YearsTest for Attentional Performance - TAP (Zimmermann & Fimm, 2002) at baseline and then after 1 years, 5 years and 10 years after the first seizure: reaction time in ms, standard deviation of the reaction time, ratio of errors ratio of correct reactions
Relationsship status10 yearsRelationship status (single, maried, divorced) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Copy and recall of the Rey-Osterrieth Figure10 YearsCopy and recall of the Rey-Osterrieth Figure (Berry, Allen, & Schmitt, 1991) at baseline and then after 1 years, 5 years and 10 years after the first seizure: 0 to 36 points. 0 worst possible result, 36 best possible result.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026