Intracranial TumorVISTANCT00936806
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 of Intracranial Tumor, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Tumor
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.
- Conditions
- Intracranial Tumor
- Keywords
- Intracranial tumor patients
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral intracranial tumor | Subjects with unilateral intracranial tumor | |
| Control group | Subjects without intracranial pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.
Measured: 2 years
Secondary outcomes (1)
Covariates that causes asymmetry between bilaterally derived EEG.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Hugo Vereecke, MD PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936806
- Sponsor's protocol ID
- 2008/666
- Acronym
- VISTA
- Status last verified
- Jan 2014
- First submitted
- 9 Jul 2009
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00936806
- Acronym / sponsor ID
- VISTA / 2008/666
- Conditions
- Intracranial Tumor
- Keywords
- Intracranial tumor patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral intracranial tumor | – | –Subjects with unilateral intracranial tumor |
| Control group | – | –Subjects without intracranial pathology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.
Time frame: 2 years
1 secondary outcome
Covariates that causes asymmetry between bilaterally derived EEG.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo Vereecke, MD PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Tumor, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.