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OpenTrials
Completed

NCT Number: NCT01862952

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

starting of anti-epileptic drug treatment

Other

Primary outcomes

  1. Functional outcome

    Time frame: day 7

    Modified ranking scale and NIHSS

  2. Functional outcome

    Time frame: at month 6

    Modified ranking scale and NIHSS

Secondary outcomes

  1. Mortality

    Time frame: at month 6

    medical records, seizure diary, interrogation of patient and caregiver

  2. occurrence of epileptic seizures

    Time frame: at month 6

    medical records, seizure diary, interrogation of patient and caregiver

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: Video-EEG

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 27, 2013
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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