RecruitingNot Applicable

Seizure Recurrence After Unprovoked First Seizure

Canada275 participantsStarted 2023-08-01

Plain-language summary

One in 10 people have a seizure during their life. Usually no cause is identified. Seizures without an identified cause are called unprovoked first seizure (UFS). Most people with UFS do not have further seizures. Being able to predict the risk of more seizures as soon as possible would help doctors decide whether to suggest treatment after UFS. Studies show that seizures are associated with changes in brain structure and function that are difficult to detect with standard assessments but can be detected with advanced techniques. Changes in connections between brain regions are also linked to subtle problems in thinking and mood. The investigators will examine brain connections using detailed brain scans, thinking, and mood in people with UFS and develop an accurate method for calculating the risk of further seizures. 200 adult patients and 75 matched healthy controls from the Halifax and Kingston First Seizure Clinics will undergo cognitive screening assessment of major cognitive domains, MRI imaging including structural scans, resting-state functional MRI (rsfMRI) and diffusion-weighted imaging (DWI), and EEG. Seizure recurrence will be assessed prospectively and a multimodal machine learning model will be trained to predict seizure recurrence at 12 months.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * This study will consider adult patients between the ages of 18-65 years seen in the First Seizure Clinics in Halifax and Kingston with unprovoked first seizure. * The investigators will also include a sample of age, sex, and education-matched healthy controls with the same exclusion criteria. Exclusion Criteria: * Individuals over the age of 65 will not be included to reduce the probability of including individuals with early dementia. * The investigators will also exclude individuals who, upon assessment during their first clinic appointment, are determined to have non-epileptic events, recurrent events or diagnosis of epilepsy (e.g. based on abnormal CT or EEG), provoked seizure (e.g. medication, substance misuse, metabolic), acute symptomatic seizures, those with an existing prescription for antiseizure drugs, significant CNS comorbidity that may affect cognition and brain networks (e.g. progressive neurological disorder, MS), previous neurosurgery, or contraindication to MRI. * Finally, although there is no known risk to a fetus from MRI scanning, as is standard in research studies involving MRI, pregnant participants will be excluded and those that suspect that they may be pregnant require a negative pregnancy test before scanning.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Seizure Recurrence after Unprovoked First Seizure

Timeframe: 12 months

Trial details

NCT IDNCT05724719

SponsorDr. Gavin Winston

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

Contact for this trial

Christopher Hlynialuk, MSc

613-533-6000 hlynialuk.c@queensu.ca

View on ClinicalTrials.gov More Single Seizure trials