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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
Dalhousie University and Nova Scotia Health Authority
RECRUITING
Halifax
Queen's University and Kingston Health Sciences Centre
RECRUITING
Kingston
Contact Information
Primary
Christopher Hlynialuk, MSc
hlynialuk.c@queensu.ca
613-533-6000
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 275
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority
Leads: Dr. Gavin Winston

This content was sourced from clinicaltrials.gov