EPI-NY: Improving Diagnostics and Care After First Seizure
Trial ID: NCT06814665
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-01-24
Completion date: 2029-01-24
Sponsor: Haukeland University Hospital
Conditions: First Suspected Epileptic Seizure
Locations: Haukeland University Hospital
Countries: Norway
Enrollment: 200
Age range: None - None
Sex: ALL

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.

Outcomes:
Incidence of first seizure and new-onset epilepsy; Percent diagnostic EEG; Sensitivity, specificity, accuracy of human vs human-AI-assisted EEG analysis to predict future epilepsy; Seizure control in new-onset epilepsy; Seizure-related trauma; Loss of driving license; Loss of labor market participation; New-onset psychiatric diagnoses