Seizure, EpilepticEFS-ILAE2014NCT06836687
Effect of the New Definition of Epilepsies of the ILAE of 2014 on the Diagnosis After the First Seizure
An observational study of Seizure, Epileptic and Neuropsychology, run by University Hospital Marburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizure, Epileptic, Neuropsychology, Outcome
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 1 Aug 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with an nunprovoked epileptic seizure
Who may be able to join
- 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
Who cannot join
- Chronic drug or alcohol abuse in the last two years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
c/o Klinik für Neurologie
Marburg, Hesse, 35043
Lena Habermehl, MD, 00496421-5865435, lhaberme@med.uni-marburg.de
Susanne Knake, MD, 00496421-5865435, knake@med.uni-marburg.de
About this study
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
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.
Read the 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.
- Conditions
- Seizure, Epileptic, Neuropsychology, Outcome
- Keywords
- First epileptic seizure, Definition of epilepsy, Neuropsychology, outcome
- Medical subject headings
- Seizures
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of seizure recurrency
Seizure recurrency is recorded 6 months, 1 year, 3 years, 5 years and 10 years after the first seizure
Measured: 10 Years
Secondary outcomes (10)
employment
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.
Measured: 10 years
Salary
Gross salary in Euro at the first attack, after 6 months, 1, 3, 5 and 10 years.
Measured: 10 years
Driving restriction
Fitness to drive (yes/no) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Measured: 10 Years
Verbale Lern- und Merkfähigkeitstest
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.
Measured: 10 years
Regensburger Wortflüssigkeits-Test
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)
Measured: 10 Years
Copy and recall of the Rey-Osterrieth Figure
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.
Measured: 10 Years
Trailmaking Test A & B
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
Measured: 10 Years
Wechsler Adult Intelligence Scale - WAIS IV
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)
Measured: 10 Years
TAP
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
Measured: 10 Years
Relationsship status
Relationship status (single, maried, divorced) is assessed after the first attack, after 6 months, 1, 3, 5 and 10 years.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Mar 2018
- Primary completion1 Apr 2038 (estimated)
- Study completion1 Aug 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seizure, EpilepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Habermehl, University Hospital Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836687
- Sponsor's protocol ID
- AZ 199/17
- Acronym
- EFS-ILAE2014
- Status last verified
- Feb 2025
- First submitted
- 19 Mar 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weil J, Linka L, Gurschi M, Kidik SA, Fuchs A, Schoenfeldt R, Zahnert F, Moller L, Menzler K, Kemmling A, Knake S, Habermehl L. The impact of white matter lesions on seizure recurrence after first epileptic seizures in the elderly: a prospective study. Neurol Res Pract. 2025 May 20;7(1):36. doi: 10.1186/s42466-025-00391-2.
PubMed 40394715
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06836687
- Acronym / sponsor ID
- EFS-ILAE2014 / AZ 199/17
- Conditions
- Seizure, Epileptic, Neuropsychology, Outcome
- Keywords
- First epileptic seizure, Definition of epilepsy, Neuropsychology, outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital MarburgUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2038 (estimated)
- Study completion
- 1 Aug 2038 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with an nunprovoked epileptic seizure
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic drug or alcohol abuse in the last two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcomes
employment
Time frame: 10 years
Salary
Time frame: 10 years
Driving restriction
Time frame: 10 Years
Verbale Lern- und Merkfähigkeitstest
Time frame: 10 years
Regensburger Wortflüssigkeits-Test
Time frame: 10 Years
Copy and recall of the Rey-Osterrieth Figure
Time frame: 10 Years
Trailmaking Test A & B
Time frame: 10 Years
Wechsler Adult Intelligence Scale - WAIS IV
Time frame: 10 Years
TAP
Time frame: 10 Years
Relationsship status
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 40394715Weil J, Linka L, Gurschi M, Kidik SA, Fuchs A, Schoenfeldt R, Zahnert F, Moller L, Menzler K, Kemmling A, Knake S, Habermehl L. The impact of white matter lesions on seizure recurrence after first epileptic seizures in the elderly: a prospective study. Neurol Res Pract. 2025 May 20;7(1):36. doi: 10.1186/s42466-025-00391-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizure, Epileptic and Neuropsychology, run by University Hospital Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of seizure recurrency (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836687, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.