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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
  Purpose

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.


Condition Intervention
Stroke Other: starting of anti-epileptic drug treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Continuous Video- EEG Monitoring in the Acute Phase in Patients With a Cerebrovascular Attack- Randomisation of a Subpopulation Regarding Treatment Strategy

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Functional outcome [ Time Frame: day 7 ]
    Modified ranking scale and NIHSS

  • Functional outcome [ Time Frame: at month 6 ]
    Modified ranking scale and NIHSS


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: antiepileptic treatment as used in daily clinical practice
Antiepileptic treatment as used in daily clinical practice.
Other: starting of anti-epileptic drug treatment
No Intervention: No medication

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862952


Contacts
Contact: Veerle De Herdt, MD, Phd Veerle.deherdt@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Veerle De Herdt, MD, Phd         
Contact: Dimitri Hemelsoet, MD         
Principal Investigator: Veerle De Herdt, MD, Phd         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Veerle De Herdt, MD, Phd Ghent University Hospital, Department of Neurology
  More Information

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01862952     History of Changes
Other Study ID Numbers: EC/2013/211
First Submitted: May 14, 2013
First Posted: May 27, 2013
Last Update Posted: October 13, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Anticonvulsants