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.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00936806
First received: July 9, 2009
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.


Condition
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Covariates that causes asymmetry between bilaterally derived EEG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
Unilateral intracranial tumor
Subjects with unilateral intracranial tumor
Control group
Subjects without intracranial pathology

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent

Criteria

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.
  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: NCT00936806

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Covidien
Investigators
Principal Investigator: Hugo Vereecke, MD PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00936806     History of Changes
Other Study ID Numbers: 2008/666
Study First Received: July 9, 2009
Last Updated: January 27, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Intracranial tumor patients

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014