First Suspected Epileptic SeizureEPI-NYNCT06814665
Improving Diagnostics and Care After First Seizure
An observational study of First Suspected Epileptic Seizure, run by Haukeland University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- First Suspected Epileptic Seizure
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 24 Jan 2025to 24 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: First epileptic seizure, or multiple previous seizures not evaluated by a neurologist or child neurologist
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5021
Jan Brogger, MD PhD, 4755975058
Tom Eichele, MD PhD, 4755975103, tom.eichele@helse-bergen.no
About this study
Official title: 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.
Read more
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
- Keywords
- epilepsy, first seizure, early epilepsy, EEG, AI
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 2 years
Seizure control in new-onset epilepsy
Among patients with new-onset epilepsy, the percentage suffering no new epileptic seizures will be measured.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Secondary outcomes (7)
Time to review EEG
The time to review EEG will also be compared between expert vs expert-AI-assisted EEG analysis
Measured: 2 years
QOLIE31
Adults will be followed longitudinally with self-reported measures of quality of life (QOLIE31)
Measured: 2 years
GAD7
Adults will be followed longitudinally with self-reported anxiety (GAD7)
Measured: 2 years
Brief COPE
Adults will be followed longitudinally with self-reported coping (Brief COPE)
Measured: 2 years
Kindl
Children will be followed longitudinally with parent-reported quality of life (Kindl)
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start24 Jan 2025
- Primary completion24 Jan 2027 (estimated)
- Study completion24 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Suspected Epileptic SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Brogger, MD PhD, Principal investigator, Helse-Bergen HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814665
- Sponsor's protocol ID
- 807588
- Acronym
- EPI-NY
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: GDPR makes this very difficult
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPI-NY: Improving Diagnostics and Care After First Seizure
- ClinicalTrials.gov ID
- NCT06814665
- Acronym / sponsor ID
- EPI-NY / 807588
- Conditions
- First Suspected Epileptic Seizure
- Keywords
- epilepsy, first seizure, early epilepsy, EEG, AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 24 Jan 2027 (estimated)
- Study completion
- 24 Jan 2029 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- First epileptic seizure, or multiple previous seizures not evaluated by a neurologist or child neurologist
Key inclusion criteria (6 listed)
- The patient has experienced events with a substantial suspicion of being an epileptic seizure. One of:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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).
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.
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
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
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
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
7 secondary outcomes
Time to review EEG
Time frame: 2 years
QOLIE31
Time frame: 2 years
GAD7
Time frame: 2 years
Brief COPE
Time frame: 2 years
Kindl
Time frame: 2 years
Mortality
Time frame: 2 years
School absence days
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No. GDPR makes this very difficult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jan Brogger, MD PhD principal investigator
Helse-Bergen HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of First Suspected Epileptic Seizure, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Brøgger, MD PhD (4755975058, jan.brogger@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of first seizure and new-onset epilepsy (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.