RecruitingNAINTERVENTIONAL

The Clinical Utility of BioEP in Diagnostic Decision Making in Epilepsy

This study, called BioEP, is for adults who've had a suspected first seizure. Doctors often use tests like EEGs, MRI scans, and blood tests, along with patient stories, to figure out what's happening. This study wants to see if adding a new computer-based tool, also called BioEP, alongside these usual methods can help doctors make a more accurate and quicker diagnosis of epilepsy. Researchers are hoping to make the BioEP tool even better by using the information they gather during this study. Half the participants will get the usual care, and the other half will get usual care plus the new BioEP information to help guide their doctors.

At a glance

Status

Recruiting

Phase

Sponsor

Neuronostics Ltd

Enrolment target

559

Start

21 May 2024

Estimated completion

31 Dec 2026

Epilepsy

What is this study about?

Imagine you've had a suspected first seizure, and your doctor is trying to figure out if it's epilepsy or something else. This study is all about helping doctors make that decision more accurately and perhaps more quickly. It's called "BioEP" and it's trying to introduce a new computer-assisted tool to help with diagnosis.

Currently, when you see a doctor after a suspected seizure, they'll gather lots of information. This includes asking about your health history, what happened during the seizure, and they might order tests like an EEG (which measures brain activity), an MRI scan (which takes pictures of your brain), or blood tests. These are all part of 'usual care'.

This study will compare what happens when doctors use only these usual care methods versus when they use usual care alongside information from the new BioEP tool. The BioEP tool processes information from your EEG to give doctors an extra piece of information to consider. By doing this, the researchers hope to see if BioEP is useful for doctors in making a diagnosis and also learn how to improve the tool for the future, making it even better at helping people like you.

The study aims to understand if adding BioEP helps doctors decide if someone has epilepsy. This could potentially lead to clearer diagnoses and getting people the right support sooner. It's an important step in making sure people with suspected seizures get the best possible care.

Key takeaways

This study evaluates a new tool, BioEP, for diagnosing epilepsy.
It compares standard care with standard care plus BioEP information.
Participants are adults who've had a suspected first seizure.
The study aims to improve diagnosis accuracy and the BioEP tool itself.
Your involvement helps advance understanding of epilepsy diagnosis.

Who may be eligible?

This study is looking for adults aged 18 and older who have recently had their very first suspected seizure. You would need to be able to understand the study and agree to take part. Doctors would need to recommend an EEG scan for you based on your history of seizures. Importantly, if you took part, your first EEG scan should not show any clear signs that immediately confirm epilepsy.

You wouldn't be able to join the study if you can't have an EEG test, or if you have certain other conditions, like known liver or kidney problems that affect your brain. Also, if your doctor already knows for sure that something else, not epilepsy, caused your symptoms (for example, a simple faint), then this study wouldn't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had your first suspected seizure recently?
Has your doctor recommended you have an EEG scan?
Does your EEG scan not show clear signs of epilepsy right away?
Do you not have other specific conditions like serious liver or kidney problems affecting your brain, or another clear diagnosis for your symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of two groups, like flipping a coin, so it's fair. One group will receive the usual care from your doctor, which involves all the standard tests and discussions. The other group will receive usual care, but your doctors will also get extra information from the BioEP tool to help them with your diagnosis.

All participants will have an EEG scan as part of their usual care. Researchers will follow your progress for two years after you join the study to see how things develop. The study itself will be recruiting new people for about one year.

Potential risks and benefits

Taking part in a study like this helps improve medical knowledge for everyone in the future. There's a chance that the BioEP information could help your doctor make a more accurate or faster diagnosis for you, but this isn't guaranteed. Since BioEP is being studied, we don't know for sure how much it will help yet. There are no known physical risks directly from the BioEP tool itself, as it uses information from scans you would have anyway. Your medical care would continue as usual. You are always free to change your mind and leave the study at any time, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Cornwall Hospitals Trust
Verified postcode
Truro, United Kingdom· Recruiting
The Royal Wolverhampton NHS Trust
Verified postcode
Wolverhampton, United Kingdom· Recruiting

Common questions

What is an EEG?

An EEG (electroencephalogram) is a test that measures the electrical activity in your brain. Small sensors are placed on your scalp, and it's a painless procedure.

What is 'usual care'?

'Usual care' means the standard medical check-ups, tests, and discussions and advice that your doctor would normally provide for someone with suspected seizures.

Will I have to take new medication?

No, this study is about helping diagnose epilepsy, not about testing new medications. Any treatment decisions would be part of your usual care, made by you and your doctor.

What happens if I don't want to continue in the study?

You are free to withdraw from the study at any time, for any reason. It will not affect the quality of your medical care.

How long will I be involved in the study?

If you join, researchers will follow your health for two years to see how your condition develops and what the final diagnosis is.

How to find out more

Wessel Woldman

w.woldman@neuronostics.com +44 (0)117 457 2292 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.