Recruiting

Observational Study

Sponsor:

Dr. Gavin Winston

Code:

NCT05724719

Conditions

Single Seizure

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Single Seizure

Epilepsy

Study ID

NCT05724719

Start date

Aug 1, 2023

Status verified date

Oct, 2024

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

275 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Number of Participants with Seizure Recurrence after Unprovoked First Seizure [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Christopher Hlynialuk, MSc

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

Locations

Dalhousie University and Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Isaac Cormier, BSc

902-473-4263isaac.cormier@nshealth.ca

Queen's University and Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Christopher Hlynialuk, MSc

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

More Information

Sponsor

Dr. Gavin Winston

Last update posted

Oct 17, 2024

Last verified

Oct, 2024

Keywords

  • Cognition
  • Mood
  • Brain Connectivity
  • Neuroimaging
  • Neurophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Gavin Winston on 2024-10-17.