Clinical trial NCT06814665: Improving Diagnostics and Care After First Seizure
Official title: EPI-NY: Improving Diagnostics and Care After First Seizure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: First Suspected Epileptic Seizure
Keywords: epilepsy
first seizure
early epilepsy
EEG
AI
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First epileptic seizure, or multiple previous seizures not evaluated by a neurologist or child neurologist

Brief summary: A first epileptic seizure is a distressing experience, often leading to a complicated and discouraging journey before an epilepsy diagnosis is confirmed. Early diagnostics can help alleviate this uncertainty. It is important to note that seizure mimics and suspected epilepsy are more frequently encountered than an actual first diagnosis of epilepsy or an epileptic seizure. Conversely, delays in diagnosing epilepsy are also common. The current evidence base on first events that may be epileptic remains limited.

First seizure clinics, which provide specialized care for these cases, are becoming more common globally, but none have yet been established in Norway. There is a pressing need to assess the prevalence of first-seizure-like events in Bergen and the surrounding areas, as well as to investigate the clinical trajectory before and after an epilepsy diagnosis. EEG is the cornerstone of diagnostic testing for epilepsy after first seizure, and recent advancements have introduced artificial intelligence to enhance the accuracy of EEG-based epilepsy identification.

The investigators will identify in one year around 200 hospital-handled patients who had had an episode that may be epileptic. Patient will be followed up over two years, with data abstracted from the medical record regarding seizure diagnosis, new events, new brain-related diagnoses and complications. Data will also be gathered from government databases in primary and secondary care regarding complications from seizure, new brain-related diagnoses, new brain-related medications, sickness absence and income. For children, school absence days will be collected.

The investigators will identify the incidence of first seizure and new-onset epilepsy, and and which care pathways most patients with suspected first seizure go through. The investigators will study the role of early EEG to reduce diagnostic uncertainty, and compare conventional EEG interpretation with AI-assisted interpretation for diagnostic precision. The investigators will study the trajectory of anxiety, quality of life and complications with record linkage for epilepsy-relevant outcomes. A broad scope of complications will be studied, including job or school absence, driving license status, injuries in primary or secondary care, and new brain-related diagnoses. This study will gather important data to gauge potential gaps and improvements in care in early epilepsy, of relevance to patients in Bergen, Norway and the developed part of the world.

Particulary novel aspects are an evaluation of the SCORE AI model for EEG analysis, and linking to a spectrum of government databases on work participation, primary care and specialty care on complications of first seizure and/or early epilepsy.


Eligibility criteria: Inclusion Criteria:

* The patient has experienced events with a substantial suspicion of being an epileptic seizure. One of:

  * The patient has experienced one or more first-in-life events with a substantial suspicion of being an epileptic seizure, including febrile seizures, and these episodes have previously not been evaluated by a neurologist or pediatrician OR
  * The patient has experienced the recurrence of events with a substantial suspicion of being an epileptic seizure, that have previously been evaluated by a neurologist or pediatrician to not be epileptic, and this merits a new evaluation.
  * OR: The patient does not fulfill the criteria above, but has been investigated for episodes or complaints, which after evaluation have been shown to be first-in-life epileptic seizures.

OR

-The patient has experienced the recurrence of events with a substantial suspicion of being an epileptic seizure, that have previously been evaluated by a neurologist or pediatrician to not be epileptic, and this merits a new evaluation.

Exclusion Criteria:

* Previous known clinical diagnosis of epilepsy given by a neurologist or pediatrician, and not subsequently retracted.
* Person or caregivers able to give informed consent.
* Adequate Norwegian language skills to be able to fill out questionnaires.

Primary outcomes:
measure: Incidence of first seizure and new-onset epilepsy
timeFrame: 2 years
measure: Percent diagnostic EEG
timeFrame: 2 years
measure: Sensitivity, specificity, accuracy of human vs human-AI-assisted EEG analysis to predict future epilepsy
timeFrame: 2 years
measure: Seizure control in new-onset epilepsy
timeFrame: 2 years
measure: Seizure-related trauma
timeFrame: 2 years
measure: Loss of driving license
timeFrame: 2 years
measure: Loss of labor market participation
timeFrame: 2 years
measure: New-onset psychiatric diagnoses
timeFrame: 2 years
Secondary outcomes:
measure: Time to review EEG
timeFrame: 2 years
measure: QOLIE31
timeFrame: 2 years
measure: GAD7
timeFrame: 2 years
measure: Brief COPE
timeFrame: 2 years
measure: Kindl
timeFrame: 2 years
measure: Mortality
timeFrame: 2 years
measure: School absence days
timeFrame: 2 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Helse-Bergen HF
name: Jan Brogger, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: