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CompletedNCT00936806VISTAUpdated Jan 28, 2014

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

An observational study in Intracranial Tumor, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-01-28.

Sponsored by University Hospital, Ghent · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

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Conditions studied

  • Intracranial Tumor

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Keywords

  • Intracranial tumor patients
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In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.

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Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)

Groups and cohorts

  • Unilateral intracranial tumor

    Subjects with unilateral intracranial tumor

  • Control group

    Subjects without intracranial pathology

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What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Covariates that causes asymmetry between bilaterally derived EEG.

    Time frame: 2 years

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Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00936806
Lead sponsor
University Hospital, Ghent
Collaborators
Medtronic - MITG
Responsible party
Sponsor
First posted
Jul 10, 2009
Start date
Jan 2009
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Jan 28, 2014

Study contacts

Hugo Vereecke, MD PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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