Post-stroke Seizures and EEG Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 602
- Locations
- 1
- Primary Endpoint
- post-stroke EEG characteristics
Study Overview
Brief Summary
This research aims to determine the frequency of seizures in patients following a stroke, identify risk factors associated with post-stroke seizures, and characterize EEG changes linked to these seizures. Unexplored alterations in the aperiodic component of the EEG in post-stroke patients could potentially serve as novel biological markers for epilepsy after stroke.
Detailed Description
This study included patients with stroke or post-stroke seizures who were admitted to the Neurology Division at the University Medical Centre Maribor, Slovenia, over a 12-month period. The anticipated number of patients was approximately 600-650. Inclusion criteria encompassed acute stroke or seizure occurring at any point after the stroke. Stroke classification was based on the World Health Organization (WHO) criteria, while post-stroke seizures and epilepsy were defined according to the International League Against Epilepsy (ILAE) definitions and classifications.
All participants provided written informed consent after being thoroughly informed about the study. The study was pre-approved by the Medical Ethics Committee of the Republic of Slovenia (Approval No. 48/08/14 and Approval No. 0120-302/2024-2711-3). Patients who did not meet the inclusion criteria or could not undergo diagnostic procedures as outlined in the research protocol were excluded based on principles of good clinical practice.
During the 12-month study period, demographic, imaging, laboratory, and neurophysiological data were prospectively collected from all hospitalized stroke patients.
Data Collection
Patient history was utilized to gather information on neurological impairments, seizure onset, and risk factors for cerebrovascular diseases. For patients who experienced seizures, the interval between stroke onset and seizure occurrence (in days) was calculated to distinguish early from late post-stroke seizures.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients were eligible for inclusion if they had experienced an acute stroke or a seizure occurring at any point after a previous stroke.
Exclusion Criteria
- •Patients were excluded from the study if they did not meet the inclusion criteria or if diagnostic procedures could not be performed in accordance with the research protocol. Exclusions were made following good clinical practice principles.
Arms & Interventions
EEG+/EPI- group
Patients with epileptiform EEG changes but no seizures
EEG-/EPI-group
Patients without epileptiform EEG changes and no seizures
KON group
A control group of comparable healthy individuals
EEG+/EPI+ group
Patients with epileptiform EEG changes and seizures
Outcomes
Primary Outcomes
post-stroke EEG characteristics
Time Frame: From enrollment of first patient to the last one in 12 months
Investigators are interested in specific EEG changes which may indicate risk factors for post-stroke seizures
Post-stroke seizure prevalence
Time Frame: From enrollment of first patient to the last one in 12 months
Risk factors of post-stroke seizures
Time Frame: From enrollment of first patient to the last one in 12 months
Investigators are interested in serum and radiological biomarkers as risk factors for post-stroke seizures
Secondary Outcomes
- Aperiodic EEG component in patients after stroke with and without seizures(From enrollment to the end of hospitalisation)
Investigators
Albin Gačnik MD
MD, Senior Consultant Neurologist
University Medical Centre Maribor