- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00936806
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)
January 27, 2014 updated by: University Hospital, Ghent
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.
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Unilateral intracranial tumor
Subjects with unilateral intracranial tumor
|
Control group
Subjects without intracranial pathology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Covariates that causes asymmetry between bilaterally derived EEG.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hugo Vereecke, MD PhD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 9, 2009
First Submitted That Met QC Criteria
July 9, 2009
First Posted (Estimate)
July 10, 2009
Study Record Updates
Last Update Posted (Estimate)
January 28, 2014
Last Update Submitted That Met QC Criteria
January 27, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/666
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Intracranial Tumor
-
Technical University of MunichCarl Zeiss Meditec AGCompleted
-
Chengcheng GuoRecruitingSurgery | Intracranial Germ Cell Tumor | Intracranial Germ Cell CNS Tumor, ChildhoodChina
-
Samsung Medical CenterCompletedBrain Tumor | General Anesthesia | Cerebral Aneurysm | Neurosurgery | Spine Tumor | Motor Evoked Potential MonitoringKorea, Republic of
-
Beijing Neurosurgical InstituteUnknownIntracranial Germ Cell TumorChina
-
The Cleveland ClinicCompletedAdult Solid Tumor | Adult Intracranial TumorUnited States
-
Peking Union Medical College HospitalNot yet recruitingIntracranial Tumor
-
Akdeniz UniversityCompletedIntracranial Hypertension | Intracranial Aneurysm | Intracranial Tumor | Epileptic Seizure | Vertebra; AnomalyTurkey
-
Kantonsspital AarauCompleted
-
Children's Oncology GroupNot yet recruitingChildhood Central Nervous System Germinoma | Intracranial Germ Cell Tumor
-
University Hospital MuensterHannover Medical School; Deutsche Kinderkrebsstiftung; Gesellschaft fur Padiatrische...UnknownIntracranial Germ Cell TumorsGermany