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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 (Video-EEG)

This study is currently recruiting participants.
Verified October 2017 by University Hospital, Ghent
Sponsor:
ClinicalTrials.gov Identifier:
NCT01862952
First Posted: May 27, 2013
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
May 14, 2013
May 27, 2013
October 13, 2017
June 2013
December 2018   (Final data collection date for primary outcome measure)
  • Functional outcome [ Time Frame: day 7 ]
    Modified ranking scale and NIHSS
  • Functional outcome [ Time Frame: at month 6 ]
    Modified ranking scale and NIHSS
Same as current
Complete list of historical versions of study NCT01862952 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: at month 6 ]
    medical records, seizure diary, interrogation of patient and caregiver
  • occurrence of epileptic seizures [ Time Frame: at month 6 ]
    medical records, seizure diary, interrogation of patient and caregiver
Same as current
Not Provided
Not Provided
 
Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Stroke
Other: starting of anti-epileptic drug treatment
  • Active Comparator: antiepileptic treatment as used in daily clinical practice
    Antiepileptic treatment as used in daily clinical practice.
    Intervention: Other: starting of anti-epileptic drug treatment
  • No Intervention: No medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Veerle De Herdt, MD, Phd Veerle.deherdt@ugent.be
Belgium
 
 
NCT01862952
EC/2013/211
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Veerle De Herdt, MD, Phd Ghent University Hospital, Department of Neurology
University Hospital, Ghent
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP