Develop and implement a new functional MRI protocol for function mapping in young children.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Similarity amongst fMRI activation patterns of healthy controls
- Match between fMRI activation pattern and standard diagnostic results in
epilepsy patients
Secondary outcome
NVT
Background summary
For children with epilepsy, epilepsy surgery (i.e. surgical removal of the
source of the seizures) can be a highly effective treatment. Before surgery is
performed, it is crucial to know the lateralization and localisation (together
*mapping*) of essential brain areas, for example for movement or language, in
order to prevent damage due to surgery. Functional MRI is one of the most
precise non-invasive tools that can be used for localising brain areas, and is
increasingly applied in the presurgical work-up of adult epilepsy patients. For
children, however, it is not always possible to obtain reliable fMRI results,
because current fMRI protocols are developed for adults and do not match the
interests, level of functioning and the experience of (young) children. In the
current project, we aim to make high quality functional mapping available for
young pediatric epilepsy patients. Having a reliable tool for function mapping
in this group will reduce the need for more invasive function localization
procedures, increase the number of children eligible for surgery, and optimize
surgical decision making and the outcome of the eventual epilepsy surgery.
Study objective
Develop and implement a new functional MRI protocol for function mapping in
young children.
Study design
Observational study.
Study burden and risks
No direct benefits are expected for the subjects of the current study, but the
study is expected to contribute to the availability of high-quality functional
mapping for future pediatric epilepsy patients. After informed consent,
subjects will fill out two questionnaires (Edinburgh Handedness Inventory to
determine left-right handedness, and fMRI safety screening form). All children
will perform a practice scanning session in a *mock-scanner* (no field) before
the actual scan, in order to familiarize them with the MRI setting and practice
the tasks. Subsequently, subjects will perform an fMRI session (3Tesla). There
are no known risks associated with fMRI acquisition and the risk and burden of
participating in the study are considered negligible.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Pilot phase and phase 2:
- Healthy subjects (m/f)
- Age 6-10;Phase 3:
- Epilepsy patients (m/f) scheduled for epilepsy surgery
- Age 6-10 or older with a mental age equivalent to this age range. The patients neurologist/neuropsychologist will decide whether older patients meet this criteria by evaluating the results of the patients neuropsychological assessment which includes IQ testing with for example the WPPSI-III-NL or WISC-III-NL. These tests are part of the clinical examination procedures and are performed by all epileptic patients who might require surgery
Exclusion criteria
- Metal objects in the body that are not MRI compatible
- Anxiety in the scanner (evaluated by parent/caretaker, or after practice in mock scanner)
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 | NL57524.041.16 |