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 is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Collaborator:
Covidien
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00936806
First received: July 9, 2009
Last updated: February 1, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00936806
Contacts
| Contact: Barbara Wyler | barbara.wyler@ugent.be |
Locations
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Contact: Barbara Wyler barbara.wyler@ugent.be | |
| Principal Investigator: Stefan De Hert, MD PhD | |
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: | February 1, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
Intracranial tumor patients |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013