Improving Diagnostics and Care After First Seizure (EPI-NY)

EPI-NY: 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.

Study Overview

• Status: Recruiting
• Conditions: First Suspected Epileptic Seizure

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jan Brøgger, MD PhD; Phone Number: 4755975058; Email: jan.brogger@helse-bergen.no
• Study Contact Backup: Name: Tom Eichele, MD PhD; Phone Number: 4755975103; Email: tom.eichele@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University Hospital
    • Contact: Tom Eichele, MD PhD; Phone Number: 4755975103; Email: tom.eichele@helse-bergen.no
    • Contact: Jan Brogger, MD PhD; Phone Number: 4755975058
    • Contact: Jan Brogger, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

First epileptic seizure, or multiple previous seizures not evaluated by a neurologist or child neurologist

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
First epileptic seizure; The patient has experienced one or more first-in-life events with a substantial suspicion of being an epileptic seizure, excluding febrile seizures, and these episodes have previously not been evaluated by a neurologist or pediatrician
New evaluation of possible seizures previously thought to be non-epileptic; 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.
New epilepsy diagnosis in the study period not otherwise included; The patient does not fulfill the criteria for the two other groups, but has been investigated for episodes or complaints, which after evaluation have been shown to be first-in-life epileptic seizures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of first seizure and new-onset epilepsy	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 years
Percent diagnostic EEG	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	2 years
Sensitivity, specificity, accuracy of human vs human-AI-assisted EEG analysis to predict future epilepsy	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).	2 years
Seizure control in new-onset epilepsy	Among patients with new-onset epilepsy, the percentage suffering no new epileptic seizures will be measured.	2 years
Seizure-related trauma	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	2 years
Loss of driving license	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	2 years
Loss of labor market participation	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	2 years
New-onset psychiatric diagnoses	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to review EEG	The time to review EEG will also be compared between expert vs expert-AI-assisted EEG analysis	2 years
QOLIE31	Adults will be followed longitudinally with self-reported measures of quality of life (QOLIE31)	2 years
GAD7	Adults will be followed longitudinally with self-reported anxiety (GAD7)	2 years
Brief COPE	Adults will be followed longitudinally with self-reported coping (Brief COPE)	2 years
Kindl	Children will be followed longitudinally with parent-reported quality of life (Kindl)	2 years
Mortality	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	2 years
School absence days	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	2 years

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Jan Brogger, MD PhD, Helse-Bergen HF

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2029

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: epilepsy; EEG; AI; first seizure; early epilepsy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Seizures
• Other Study ID Numbers: 807588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: GDPR makes this very difficult

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No