NCT06814665: EPI-NY

Improving Diagnostics and Care After First Seizure

Recruiting now Last updated 7 February 2025

What this trial tests

trial in First Suspected Epileptic Seizure in 200 participants. Currently enrolling.

Timeline

24 January 2025

Primary endpoint
24 January 2027

24 January 2029

Quick facts

Lead sponsor	Haukeland University Hospital
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	200
Start date	24 January 2025
Primary completion	24 January 2027
Estimated completion	24 January 2029
Sites	1 location across Norway

Conditions studied

• First Suspected Epileptic Seizure — all drugs for First Suspected Epileptic Seizure →

Sponsor

Haukeland University Hospital

Who can join

Eligibility, any sex, with First Suspected Epileptic Seizure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.