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NCT Number: NCT06836687

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

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.

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Key information

Conditions

Seizure, Epileptic Nervous System Diseases Neurologic Manifestations Neuropsychology Outcome Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Salary

    Time frame: 10 years

    Gross salary in Euro at the first attack, after 6 months, 1, 3, 5 and 10 years.

  3. 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.

  4. 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.

  5. 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)

  6. 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.

  7. 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

  8. 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)

  9. 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. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Marburg

Other

Registry information

Official study 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

Acronym: EFS-ILAE2014

Important dates

Study start
2018
Primary completion
2038
Study completion
2038
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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