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

NCT00936806 | Completed

• 1 other identifier: 2008/666
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Tumor

Keywords

Intracranial tumor patients

Outcome Measures

Primary Outcomes (1)

• Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.

  2 years

Secondary Outcomes (1)

• Covariates that causes asymmetry between bilaterally derived EEG.

  2 years

Study Arms (2)

Unilateral intracranial tumor

Subjects with unilateral intracranial tumor

Control group

Subjects without intracranial pathology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Medtronic - MITG: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• website of the University Hospital Ghent

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hugo Vereecke, MD PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

BE (1)