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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.


N/A
18 Years
80 Years
Open (Enrolling)
Both
Intracranial Tumor

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Hugo Vereecke, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Institutional Review Board

Study ID:

2008/666

NCT ID:

NCT00936806

Start Date:

January 2009

Completion Date:

December 2013

Related Keywords:

  • Intracranial Tumor
  • Intracranial tumor patients
  • Brain Neoplasms

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