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

NCT ID: NCT01862952

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-01

Study Completion Date

2018-12-01

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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antiepileptic treatment as used in daily clinical practice

Antiepileptic treatment as used in daily clinical practice.

Group Type ACTIVE_COMPARATOR

starting of anti-epileptic drug treatment

Intervention Type OTHER

No medication

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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starting of anti-epileptic drug treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veerle De Herdt, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Ghent University Hospital, Department of Neurology

Locations

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Ghent University Hospital

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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EC/2013/211

Identifier Type: -

Identifier Source: org_study_id