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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

NCT01862952 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-09

No results posted yet for this study

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.

Conditions

Interventions

OTHER

starting of anti-epileptic drug treatment

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Veerle De Herdt, MD, Phd · Ghent University Hospital, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-01
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01862952 on ClinicalTrials.gov