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Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia: Comparison With a Control Group Without Intracranial Pathology (VISTA)

This study has been completed.
Medtronic - MITG
Information provided by (Responsible Party):
University Hospital, Ghent Identifier:
First received: July 9, 2009
Last updated: January 27, 2014
Last verified: January 2014
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.

Intracranial Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia. Comparison With a Control Group Without Intracranial Pathology.

Resource links provided by NLM:

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres. [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Covariates that causes asymmetry between bilaterally derived EEG. [ Time Frame: 2 years ]

Enrollment: 80
Study Start Date: January 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Unilateral intracranial tumor
Subjects with unilateral intracranial tumor
Control group
Subjects without intracranial pathology


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent

Inclusion Criteria:

  • Adult ≥ 18 - 80 years old
  • Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial
  • Scheduled for "procedure"
  • ASA Class I, II or III as assigned by the anaesthesiologist

Exclusion Criteria:

  • Allergy or inability to tolerate "product"
  • Body weight less than 70% or more than 130% of ideal body weight
  • Pregnant or nursing females
  • Participation in a clinical trial within the past 30 days
  • Congenital mental disability or congenital anatomical brain abnormality
  • A medical history of cerebrovascular accident or thrombosis
  • A medical history of carotic artery occlusive pathology
  • A medical history of degenerative cerebral pathology (MS, Dementia, ALS, para-or tetraplegia due to a traumatic disruption of the spinal cord)
  • A medical history of severe psychiatric pathology (Schizophrenia, severe depression, alcoholism, drug abuse) Mild depression evoked by coping with the diagnosis of cancer is not excluded
  • Patients with a history of epileptic insults. Patients receiving preventive anti-epileptic treatment due to the tumoral process are not excluded.
  • Patients with low cardiac output conditions due to pre-existing cardiac pathology (Cardiac insufficiency, valve pathology, dysrhythmia, myocardial infarction). Patients presenting with stable coronary artery disease with a normal myocardial function are not excluded)
  • Arterial hypertension is not an exclusion criteria, nor is the use of antihypertensive medication, except beta blockers for their potential interfering effects on spontaneous EEG.
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Please refer to this study by its identifier: NCT00936806

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Medtronic - MITG
Principal Investigator: Hugo Vereecke, MD PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00936806     History of Changes
Other Study ID Numbers: 2008/666
Study First Received: July 9, 2009
Last Updated: January 27, 2014

Keywords provided by University Hospital, Ghent:
Intracranial tumor patients

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on April 28, 2017