Observational Study of the Differences in Characteristics... | NCT00936806

Studies
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

NCT00936806

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Jan 28, 2014Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Intracranial Tumor

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jul 9, 2009

First Submission Date that Met QC Criteria

Jul 9, 2009

First Posted Date

Jul 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Label	Type	Description	Intervention Names
Unilateral intracranial tumor		Subjects with unilateral intracranial tumor
Control group		Subjects without intracranial pathology

Measure	Description	Time Frame
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.		2 years

Measure	Description	Time Frame
Covariates that causes asymmetry between bilaterally derived EEG.		2 years

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with unilateral intracranial tumor during routine anesthesia at the University Hospital Ghent

Sampling Method

Non-Probability Sample

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases