This study is aimed at two objectives: Objective 1: Development of new clinical fMRI protocols, based on existing cognitive tasks, that provide robust and reliable activation patterns, as well as performance measures that correlate woth…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hersentumoren (meningioom en laaggradige gliomen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
study 1.1: development of cognitive test paradigms suitable for fMRI, that
provide behavioral measurements that correlate with neuropsychological
performance
study 1.2: application in healthy controls of cognitive fMRI protocols based on
the best performing test paradigms from study 1.1 in order to test for
robustness and reliability
study 2.1: application in patient cohorts of cognitive best performing fMRI
protocols developed in study 2.1 to test for correlation of brain activity
measures that correlate significantly with neuropsychological performance.
Secondary outcome
NA
Background summary
Patients with brain tumors frequently suffer from cognitive impairments that
have a negative influence on their daily functioning and quality of life. These
cognitive impairments can be a direct consequence of the tumor, but they can
also be a temporary or sometimes even long-term side-effect of the surgical
treatment. To date, unfortunately, we know very little about the causes of
these impairments or the influence of treatment. There is a clear clinical need
to acquire this knowledge to improve patient counselling and optimize surgical
treatment. Currently available clinical tools for this purpose are not
sufficient.
Promising new techniques that are available to increase our knowledge are
non-invasive functional neuroimaging techniques such as fMRI. fMRI can provide
detailed information that can be used to monitor changes over time in brain
activity in brain tumor patients. In this research we aim first to develop
clinical fMRI protocols for brain tumor patients that can test cognitive
functioning, and ultimately provide information about expected cognitive
functioning after surgery.
Study objective
This study is aimed at two objectives:
Objective 1: Development of new clinical fMRI protocols, based on existing
cognitive tasks, that provide robust and reliable activation patterns, as well
as performance measures that correlate woth neuropsychological functioning.
Objective 2: Development of new clinical fMRI protocols that provide brain
activation measures that correlate with neuropsychological performance in
patients over time.
Study design
Stage 1
study 1.1
cognitive tasks performed on PC by patients
study 1.2
fMRI in healthy controls using newly developed clinical fMRI protocols based on
best performing cognitive tasks from study 1.1
Stage 2
study 2.1
fMRI in patients on best performing clinical fMRI protocols from study 1.2
Study burden and risks
The main measurement technique used in this study will is MRI. The Sint
Elisabeth Hospital has ample experience with MRI scanning and the MRI-scanner
is handled by trained personnel. There are no known risks associated with MRI
acquisition and the procedure is painless. The technique does not require
administration of any contrast agent or ionizing radiation. Slight discomfort
may occur due to noise generated by the scanner, or by lying still with the
head and part of the body confined in a tunnel-like device. The subject will be
provided with earplugs for protection from noise generated by the MRI scanner.
An intercom is available in the scanner so the subject can remain in contact
with personnel during the entire scan session. In addition, an emergency button
is placed within reach of the subject during the scan session. If a subject is
uncomfortable with any aspect of the procedure and wants to stop, the session
will be terminated immediately.
Hilvarensebeek 60
Tilburg 5022 GC
NL
Hilvarensebeek 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
Patients: Adult patients diagnosed with a glioma or meningioma, age 18 - 75
Healthy subjects: age 18 - 75
Exclusion criteria
Patients: metal objects in or around the body (braces, pacemaker, metal fragments) that are incompatible with MRI scan procedure
Healthy subjects: metal objects in or around the body (braces, pacemaker, metal fragments) that are incompatible with MRI scan procedure
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51147.028.14 |