Seizure Recurrence After Unprovoked First Seizure

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724719
• Other study ID #: DMED-2681-22
• Secondary ID: PJT-183906
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: August 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Recurrence
• Seizures

Locations

Country	Name	City	State
Canada	Dalhousie University and Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Queen's University and Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Gavin Winston	Canadian Institutes of Health Research (CIHR), Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Seizure Recurrence after Unprovoked First Seizure		12 months