Study Results
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Basic Information
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RECRUITING
275 participants
OBSERVATIONAL
2023-08-01
2026-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Unprovoked First Seizure (UFS)
Participants will undergo cognitive screening assessment, MRI imaging and EEG (if not already done) within 2-4 weeks of the initial First seizure clinic visit. Seizure recurrence will be monitored by a diary provided to each participant with details of the research team to contact in the event of a seizure. A researcher via perform telephone reminders at 3, 6, 9 and 12 months following the seizure. The primary outcome will be seizure recurrence at 12 months.
No interventions assigned to this group
Healthy Controls
Healthy control participants will complete the same neuropsychological battery, MRI scans and EEG protocols to evaluate baseline level of impairment in a healthy population and for the group comparisons of UFS to healthy controls to establish the changes already present at initial presentation with UFS.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Nova Scotia Health Authority
OTHER
Dr. Gavin Winston
OTHER
Responsible Party
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Dr. Gavin Winston
Dr. Gavin Winston, Associate Professor, Dept. of Medicine, Queen's University, Faculty-Centre for Neuroscience, Queens University
Principal Investigators
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Gavin P Winston, BM BCh, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University
Antonina Omisade, BA, PhD
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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Dalhousie University and Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Queen's University and Kingston Health Sciences Centre
Kingston, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Antonina Omisade, BA, PhD
Role: backup
Gavin P Winston, BM BCh, PhD
Role: backup
References
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Beattie BC, Batista Garcia-Ramo K, Biggs K, Boisse Lomax L, Brien DC, Gallivan JP, Ikeda K, Schmidt M, Shukla G, Whatley B, Woodroffe S, Omisade A, Winston GP. Literature review and protocol for a prospective multicentre cohort study on multimodal prediction of seizure recurrence after unprovoked first seizure. BMJ Open. 2024 Apr 5;14(4):e086153. doi: 10.1136/bmjopen-2024-086153.
Other Identifiers
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PJT-183906
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DMED-2681-22
Identifier Type: -
Identifier Source: org_study_id
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