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. (see Contacts and Locations)
Verified December 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01862952
First received: May 14, 2013
Last updated: December 12, 2013
Last verified: December 2013

May 14, 2013
December 12, 2013
June 2013
June 2016   (final data collection date for primary outcome measure)
  • Functional outcome [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    Modified ranking scale and NIHSS
  • Functional outcome [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    medical records, seizure diary, interrogation of patient and caregiver
  • occurrence of epileptic seizures [ Time Frame: at month 6 ] [ Designated as safety issue: No ]
    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: Open Label
Primary Purpose: Diagnostic
Stroke
Other: starting of anti-epileptic drug treatment
  • Active Comparator: 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 2016
June 2016   (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
Both
18 Years and older
No
Contact: Veerle De Herdt, MD, Phd Veerle.deherdt@ugent.be
Belgium
 
NCT01862952
EC/2013/211
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Veerle De Herdt, MD, Phd Ghent University Hospital, Department of Neurology
University Hospital, Ghent
December 2013

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