Understanding seizure recurrence after a first unprovoked seizure
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
This study is trying to see if brain scans and cognitive tests can help predict whether adults who have had a first seizure without a clear cause will have more seizures in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Queen's University Academic / other |
| Locations | 2 sites (Halifax, Nova Scotia and 1 other locations) |
| Trial ID | NCT05724719 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the risk of seizure recurrence in adults who have experienced an unprovoked first seizure (UFS). By utilizing advanced neuroimaging techniques, the study will analyze brain connectivity and cognitive function in 200 patients with UFS and 75 matched healthy controls. The goal is to develop a reliable method for predicting the likelihood of further seizures, which could inform treatment decisions. Participants will undergo cognitive assessments and detailed brain scans to identify subtle changes associated with seizure activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have experienced an unprovoked first seizure and are seen at the First Seizure Clinics in Halifax and Kingston.
Not a fit: Patients over the age of 65 or those with a diagnosis of epilepsy or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of seizure recurrence, allowing for timely and appropriate treatment for patients.
How similar studies have performed: Other studies have shown promise in using advanced neuroimaging to assess seizure risk, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Halifax, Nova Scotia and 1 other locations
- Dalhousie University and Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- Queen's University and Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gavin P Winston, BM BCh, PhD — Queen's University
- Study coordinator: Christopher Hlynialuk, MSc
- Email: hlynialuk.c@queensu.ca
- Phone: 613-533-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.