NCT01862952: Video-EEG

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

Completed NA Last updated 9 December 2022

What this trial tests

NA trial testing starting of anti-epileptic drug treatment in Stroke in 100 participants. Completed in 1 December 2018.

Timeline

1 June 2013

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 June 2013
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across Belgium

Drugs / interventions tested

• starting of anti-epileptic drug treatment

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. European Stroke Organisation Conference: Abstracts
   · 2018