Improving Diagnostics and Care After First Seizure

NCT ID: NCT06814665

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2029-01-24

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.

Conditions

First Suspected Epileptic Seizure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

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

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Brogger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helse-Bergen HF

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Jan Brøgger, MD PhD

Role: CONTACT

jan.brogger@helse-bergen.no

4755975058

Tom Eichele, MD PhD

Role: CONTACT

tom.eichele@helse-bergen.no

4755975103

Facility Contacts

Jan Brogger, MD PhD

Role: primary

4755975058

Tom Eichele, MD PhD

Role: backup

tom.eichele@helse-bergen.no

4755975103

Other Identifiers

807588

Identifier Type: -

Identifier Source: org_study_id