Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: starting of anti-epileptic drug treatment

• Registration Number: NCT01862952
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-27
• Study Start: 2013-06-01
• Status Verified: 2018-10
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding

Exclusion Criteria

• Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antiepileptic treatment as used in daily clinical practice	starting of anti-epileptic drug treatment	Antiepileptic treatment as used in daily clinical practice.

Primary Outcome Measures

Name	Time	Method
Functional outcome	at month 6	Modified ranking scale and NIHSS

Secondary Outcome Measures

Name	Time	Method
Mortality	at month 6	medical records, seizure diary, interrogation of patient and caregiver
occurrence of epileptic seizures	at month 6	medical records, seizure diary, interrogation of patient and caregiver

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium