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

Recruiting

• Conditions: Seizure, Epileptic; Neuropsychology; Outcome

• Registration Number: NCT06836687
• Lead Sponsor: University Hospital Marburg

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2024-03-19
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2038-04-01
• Study Completion: 2038-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of seizure recurrency	10 Years	Seizure recurrency is recorded 6 months, 1 year, 3 years, 5 years and 10 years after the first seizure

Secondary Outcome Measures

Name	Time	Method
Relationsship status	10 years	Relationship status (single, maried, divorced) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Wechsler Adult Intelligence Scale - WAIS IV	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)
employment	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.
Salary	10 years	Gross salary in Euro at the first attack, after 6 months, 1, 3, 5 and 10 years.
Driving restriction	10 Years	Fitness to drive (yes/no) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Verbale Lern- und Merkfähigkeitstest	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.
Regensburger Wortflüssigkeits-Test	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)
Copy and recall of the Rey-Osterrieth Figure	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.
Trailmaking Test A & B	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
TAP	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

Trial Locations

Locations (1)

c/o Klinik für Neurologie; 🇩🇪 Marburg, Hessen, Germany