Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy (Video-EEG)
Recruitment status was: Recruiting
Stroke is a major cause of epilepsy. The pathophysiological mechanisms of poststroke epilepsy are not known. Subclinical epileptiform discharges could contribute to the neuronal damage and influence functional outcome. Electro-encefalography (EEG) is the golden standard to detect interictal, ictal and subclinical epileptic brain activity.
Patients admitted to the stroke unit with an ischemic or hemorrhagic cerebrovascular attack will undergo a 24 hours video-EEG monitoring to detect epileptiform discharges. Clinical and paraclinical (imaging, serum markers of neuronal damage) parameters will be analysed together with the EEG results. The EEG results will be correlated with the occurence of epileptic seizures and functional outcome and mortality in the acute phase and in the long-term. When subclinical epileptic discharges are found on the EEG, patients will be asked to participate in a second part of the study where they will be randomised into a treatment (with an anti-epileptic drug) versus no-treatment group for a period of 6 months. Outcome parameters will be the occurrence of epileptic seizures, mortality and functional outcome.
Our main hypothesis is that the occurrence of subclinical epileptiform discharges during the acute phase following stroke influences functional outcome.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy|
- Functional outcome [ Time Frame: day 7 ] [ Designated as safety issue: No ]Modified ranking scale and NIHSS
- Functional outcome [ Time Frame: at month 6 ] [ Designated as safety issue: No ]Modified ranking scale and NIHSS
- Mortality [ Time Frame: at month 6 ] [ Designated as safety issue: No ]medical records, seizure diary, interrogation of patient and caregiver
- occurrence of epileptic seizures [ Time Frame: at month 6 ] [ Designated as safety issue: No ]medical records, seizure diary, interrogation of patient and caregiver
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Active Comparator: antiepileptic treatment as used in daily clinical practice
Antiepileptic treatment as used in daily clinical practice.
|Other: starting of anti-epileptic drug treatment|
|No Intervention: No medication|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862952
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Principal Investigator:||Veerle De Herdt, MD, Phd||Ghent University Hospital, Department of Neurology|