Clinical trial NCT05724719: Seizure Recurrence After Unprovoked First Seizure
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Single Seizure
Epilepsy
Keywords: Cognition
Mood
Brain Connectivity
Neuroimaging
Neurophysiology
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Nova Scotia Health Authority
First posted: 2023-02-13
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-65 years old with unprovoked first seizure; age, sex and education-matched healthy controls.

Multi-centre, the study population will consist of adults from across Atlantic Canada, and South-Eastern Ontario.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Seizure Recurrence after Unprovoked First Seizure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University and Nova Scotia Health Authority
state: Nova Scotia
city: Kingston
country: Canada
facility: Queen's University and Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Queen's University
name: Gavin P Winston, BM BCh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Antonina Omisade, BA, PhD
role: PRINCIPAL_INVESTIGATOR
References: