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
  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: 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 ] [ 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: antiepileptic treatment as used in daily clinical practice Other: starting of anti-epileptic drug treatment
No Intervention: No medication

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01862952     History of Changes
Other Study ID Numbers: EC/2013/211
Study First Received: May 14, 2013
Last Updated: December 12, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014