Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06814665

Improving Diagnostics and Care After First Seizure

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

First Suspected Epileptic Seizure Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Location status: Recruiting

Location contact

Jan Brogger, MD PhD

CONTACT

4755975058

Jan Brogger, MD PhD

PRINCIPAL_INVESTIGATOR

Tom Eichele, MD PhD

CONTACT

[email protected]

4755975103

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Incidence of first seizure and new-onset epilepsy

    Time frame: 2 years

    Based on the final two year status, or last-status carried forward, the incidence of first seizures and new-onset epilepsy will be calculated for adults and children.

  2. Percent diagnostic EEG

    Time frame: 2 years

    The diagnostic yield of early vs late yield will be categorized as routine-EEG within 24 hours, or LTM-EEG within 1 week or later. The diagnostic yield will be computed as the percentage of patients with interictal epileptiform discharges or seizure during EEG for each category and time frame for EEG, and the same for final epilepsy diagnosis

  3. Sensitivity, specificity, accuracy of human vs human-AI-assisted EEG analysis to predict future epilepsy

    Time frame: 2 years

    We will compare the results of the current clinical standard of care, which is human expert EEG interpretation, with expert-assisted AI analysis using the SCORE AI model EEG software . We will compute sensitivity, specificity, accuracy for both diagnostic pipelines applied to all EEG to predict a future epilepsy diagnosis taken from medical records, as well as subtype of epilepsy (focal, idiopathic, unknown).

  4. Seizure control in new-onset epilepsy

    Time frame: 2 years

    Among patients with new-onset epilepsy, the percentage suffering no new epileptic seizures will be measured.

  5. Seizure-related trauma

    Time frame: 2 years

    Among patients with new-onset epilepsy, what percentage suffer from seizure-related trauma in the first and subsequent eventscompared to patients with first epileptic seizure without new-onset epilepsy and compared to patients with other event diagnosis in the same time period

  6. Loss of driving license

    Time frame: 2 years

    Among patients with new-onset epilepsy, what percentage suffer from loss of driving license compared to patients with first epileptic seizure without new-onset epilepsy and compared to patients with other event diagnosis in the same time period

  7. Loss of labor market participation

    Time frame: 2 years

    Among patients with new-onset epilepsy, what percentage suffer from loss of labor market participation compared to patients with first epileptic seizure without new-onset epilepsy and compared to patients with other event diagnosis in the same time period

  8. New-onset psychiatric diagnoses

    Time frame: 2 years

    Among patients with first seizure, and new-onset epilepsy, what percentage suffer from new-onset psychiatric diagnoses compared to patients with first epileptic seizure without new-onset epilepsy and compared to patients with other event diagnosis in the same time period

Secondary outcomes

  1. Time to review EEG

    Time frame: 2 years

    The time to review EEG will also be compared between expert vs expert-AI-assisted EEG analysis

  2. QOLIE31

    Time frame: 2 years

    Adults will be followed longitudinally with self-reported measures of quality of life (QOLIE31)

  3. GAD7

    Time frame: 2 years

    Adults will be followed longitudinally with self-reported anxiety (GAD7)

  4. Brief COPE

    Time frame: 2 years

    Adults will be followed longitudinally with self-reported coping (Brief COPE)

  5. Kindl

    Time frame: 2 years

    Children will be followed longitudinally with parent-reported quality of life (Kindl)

  6. Mortality

    Time frame: 2 years

    Among patients with first seizure, and new-onset epilepsy, what percentage suffer from mortality compared to patients with first epileptic seizure without new-onset epilepsy and compared to patients with other event diagnosis in the same time period

  7. School absence days

    Time frame: 2 years

    Among children with new-onset epilepsy, what percentage suffer from increased school absence days compared to children with first epileptic seizure without new-onset epilepsy and compared to children with other event diagnosis in the same time period

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Brøgger, MD PhD

CONTACT

[email protected]

4755975058

Tom Eichele, MD PhD

CONTACT

[email protected]

4755975103

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

EPI-NY: Improving Diagnostics and Care After First Seizure

Acronym: EPI-NY

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Feb 7, 2025
Registry last updated
Feb 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.