The primary objective of this project is to create a database containing diffusion MRI (dMRI), resting state fMRI (rs-fMRI), task fMRI and neuropsychological assessment data of healthy volunteers to be used as a reference for our brain tumor…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hersentumoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study endpoint is a database containing dMRI, rs-fMRI, task fMRI
and data from (repeated) neuropsychological assessment (cognitive testing and
questionnaires) of 100 healthy volunteers across different age rangs, education
levels and sex.
Secondary outcome
n.v.t.
Background summary
In the last decade, the clinical relevance of advanced neuroimaging has
drastically increased, as these techniques can now elucidate the pathological
structure and functional alterations in various brain disorders non -
invasively. In 2014, we started with funded neuroimaging research (via
*Experiment Topzorg*) that resulted in a clinical protocol including
noninvasive diffusion MRI (dMRI), resting state MRI (rs-fMRI) and task fMRI. To
date, approximately 600 brain tumor patients have been examined with advanced
neuroimaging and approximately 1800 patients with neuropsychological screening
for clinical and research purposes.
Advanced neuroimaging can provide insights into the underlying mechanisms by
elucidating the link between brain structure, brain function, and cognitive
functioning. To get a clear understanding of the links between these factors
and the way brain lesions affect the interaction between them, a comparison of
data from brain tumor patients and healthy individuals is crucial. Although
there are several free-access brain imaging databases available, a direct
comparison between our brain tumor patients' data and the available healthy
volunteers' data is problematic. Furthermore, for some of the cognitive tests
that we use, normative data are lacking, thereby complicating the evaluation of
the performances of our patient group in terms of deviation from normal.
By running the identical clinical protocol as in our brain tumor patients,
containing an identical neuropsychological assessment and identical
neuroimaging sequences on the same MRI scanner with the same imaging hard- and
software in 100 healthy volunteers, we will create a database to be used as a
reference for our brain tumor patient data. This database can also serve as a
baseline for the comparison to other patient groups.
Study objective
The primary objective of this project is to create a database containing
diffusion MRI (dMRI), resting state fMRI (rs-fMRI), task fMRI and
neuropsychological assessment data of healthy volunteers to be used as a
reference for our brain tumor patients data for use in clinical practice and
scientific research.
Study design
In this project, healthy volunteers will participate in 2 sessions, in one
session (T1) they will go through the clinical imaging protocol, and undergo a
neuropsychological assessment (including cognitive testing and filling out
questionnaires outside the MRI scanner). The other session (T2) will be planned
three months thereafter and will only comprise a neuropsychological assessment.
Study burden and risks
There are no direct benefits expected from participation in this study for the
subjects. There are no known risks associated with neuropsychological
assessment of MRI acquisition. MRI is painless and does not require the
administration of a contrast agent or ionizing radiation. Mild discomfort may
occur due to the noise generated by the scanner, or the door lying still with
the head and part of the body in a tunnel-like device. For the rest, tingling,
muscle twitching and tension can arise. If a subject feels uncomfortable with
any aspect of the procedure and wants to stop, the session will be cut short.
Incidental findings on the MRI may occur, even though the scans are not
actively evaluated for this. Participants are informed prior to participation
about the procedure surrounding these incidental findings and need to give
consent to this.
In addition, participation in the study takes time and the participant must
adhere to the agreements made.
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Hilvarenbeekseweg 60
Tilburg 5022GC
NL
Listed location countries
Age
Inclusion criteria
- between 18 and 80 years of age
- normal or corrected-to-normal vision and hearing
Exclusion criteria
- a history of drug abuse
- a history of head trauma
- a history of significant neurological or psychiatric disorders
- metal objects in or around the body (braces, pacemaker, metal fragments)
- pregnancy
- participation in a concurrent study with neuropsychological testing
- unable to complete test battery and/or study questionnaires due to lack of
basic proficiency in
Dutch, or IQ below 85
- claustrophobia
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 | NL84430.028.23 |
Other | nummer volgt |