The objective of the study is to optimize MR sequences for scientific research on brain development in children.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Geen van bovenstaande, namelijk optimalisatie van MRI sequenties bij kinderen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Better signal to noise ratio and resolution
Reduction in scan time for a given sequence
Secondary outcome
NA
Background summary
Simultaneously with this request for METC approval, a request for METC approval
for a study called "The effects of prenatal exposure to nicotine and cannabis
on brain development at school age" has been submitted. This study needs
existing MR sequences to be optimized to the young participants of this study.
Future research plans (for which financing and METC approval requests are in
preparation) also need optimizing of MR sequences.
Study objective
The objective of the study is to optimize MR sequences for scientific research
on brain development in children.
Study design
Before an MRI is made, all children are submitted to an extensive practice
session with a mock scanner. The practice session is aimed at reducing possible
fear by preparing the child for the MRI. The child gets acquainted with the
scanner, the scan noises and learns to lay as motionless as possible during the
making of the scans. Furthermore, it is stressed that the child is always in
control and can stop the scan with a button press. After the practice session,
several MR sequences are made.
Study burden and risks
There are no known medical risks to MR scanning. Because the optimizing study
involves young participants, there is an extensive practice procedure to make
the MR scanning as comfortable and fun as possible for the children. During the
practice session (multiple sessions, if required), the child gets familiar with
the scan environment, the MR scanner and the accompanying noises. The child is
asked at several moments whether he/she enjoys the practice session and whether
he/she finds the experience scary. These are opportunities for the child to
(non-verbally) decline further participation to the study. Furthermore, the
researcher will continually monitor the behavior of the child during the
practice session and MR scanning for signs indicating that the child wishes to
stop the study. The study will be stopped immediately when the child, the
parents or the researcher want it to stop. The child will be able to watch a
video during the practice session as well as during MR scanning. There will be
several DVDs to choose from, so the child won't be bored.
s-Gravendijkwal 230
3015 CE
NL
s-Gravendijkwal 230
3015 CE
NL
Listed location countries
Age
Inclusion criteria
Age 8 and 11 years
Informed consent signed by the parents
Extra inclusion criteria for the MRI : successful ending of the training procedure
Exclusion criteria
Claustrophobia
Contra-indications for MRI
Using medicaments which can influence the results of the study
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 | NL22776.078.08 |