Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure (EFS-ILAE2014)

February 18, 2025 updated by: Lena Habermehl, University Hospital Marburg

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Hessen
  - Marburg, Hessen, Germany, 35043
    - Recruiting
    - c/o Klinik für Neurologie
    - Contact:
      
      Lena Habermehl, MD
      
      Phone Number: 00496421-5865435
      
      Email: lhaberme@med.uni-marburg.de
    - Contact:
      
      Susanne Knake, MD
      
      Phone Number: 00496421-5865435
      
      Email: knake@med.uni-marburg.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

adult patients with an nunprovoked epileptic seizure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of seizure recurrency Time Frame: 10 Years	Seizure recurrency is recorded 6 months, 1 year, 3 years, 5 years and 10 years after the first seizure	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
employment Time Frame: 10 years	Currently working as employee or independent, retirement or long-time sick-leave at the first attack, after 6 months, 1, 3, 5 and 10 years.	10 years
Salary Time Frame: 10 years	Gross salary in Euro at the first attack, after 6 months, 1, 3, 5 and 10 years.	10 years
Driving restriction Time Frame: 10 Years	Fitness to drive (yes/no) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.	10 Years
Verbale Lern- und Merkfähigkeitstest Time Frame: 10 years	Verbale 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.	10 years
Regensburger Wortflüssigkeits-Test Time Frame: 10 Years	Regensburger 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)	10 Years
Copy and recall of the Rey-Osterrieth Figure Time Frame: 10 Years	Copy 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.	10 Years
Trailmaking Test A & B Time Frame: 10 Years	Trailmaking 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	10 Years
Wechsler Adult Intelligence Scale - WAIS IV Time Frame: 10 Years	Wechsler 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)	10 Years
TAP Time Frame: 10 Years	Test 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	10 Years
Relationsship status Time Frame: 10 years	Relationship status (single, maried, divorced) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.	10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Marburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Estimated)

April 1, 2038

Study Completion (Estimated)

August 1, 2038

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)