Seizure Recurrence After Unprovoked First Seizure

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.

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Key information

Conditions

Single Seizure Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalhousie University and Nova Scotia Health Authority, Halifax, Nova Scotia, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of Participants with Seizure Recurrence after Unprovoked First Seizure

Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Hlynialuk, MSc

CONTACT

[email protected]

613-533-6000 ext. 79750

Sponsors and collaborators

Lead sponsor

Dr. Gavin Winston

Other

Collaborators

Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority

Registry information

Official study title

Multimodal Prediction of Seizure Recurrence After Unprovoked First Seizure to Guide Clinical Decision-making: a Multi-centre Study of Cognition, Mood and Brain Connectivity As Predictors

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Feb 13, 2023
Registry last updated: Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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