Our primary objective is to collect normative reference values in typically healthy developing children, aged 0 - 18 years, for EEG in combination with ERP and eyetracking, and OCT measurements (For details see also paragraph 5.1).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Healthy children
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The basic visual information processing tasks trigger reflexive responses.
Here, the main outcome measures are:
* Performance score (target seen/unseen)
* Reaction time to target fixation (milliseconds)
The more complex visual information processing tasks result in (complex) gaze
patterns based on scanning of pictures or videos. A relationship is assumed
between a person*s gaze and thoughts. Saccades, a short period in which we are
unable to see, and fixations, a longer period in which we (re)direct our
attention on specific visual features, are commonly used as outcome measures in
eye tracking research. Here, the main outcome measures are:
* Performance scores (correct yes / no)
* Fixation duration (milliseconds) * Gaze sequence
* Number of visits to targets
EEG data will be screened.
Functional connectivity of EEG is a technique that is being adopted but there
is not yet an established gold standard in the field (Nentwich 2020).
Therefore, the start will be with the parameters phase lag index and coherence,
and establish test-retest reliability in our set-up, starting with relaxed
eye-closure.
For ERP the main study parameters will be amplitude and latency of the N1-P2-N2
peaks. The ERP recordings will be preprocessed (e.g., averaging, filtering) and
analyzed using methods such as peak latency and amplitude measurements.
In OCT the total retinal thickness (TRT), the retinal nerve fiber layer
thickness (RNFL) and the ganglion cell layer (GCL) thickness are the main study
parameters and will be measured on the scan. The data processing is done by the
principal investigator with an experienced ophthalmologist regarding OCT data.
The total retinal thickness (TRT), ganglion cell layer thickness and the
retinal nerve fiber layer (RNFL) obtained from the OCT will be expressed as
mean ± standard deviation. A mean of all the nine areas of the ETDRS grid
(circle and quadrants) will be calculated.
Secondary outcome
Not applicable
Background summary
The Pediatric Brain Center (PBC) is one of the four focus areas of the Erasmus
MC Sophia Children*s Hospital. In the PBC several departments work together to
care for children with conditions of the head/brain, senses, and limbs. Most of
these patients have or are at risk of disabilities in cognition, behavior,
communication, motor function and/or participation (in daily life, e.g. school)
to a variable degree. This makes them vulnerable in society and we recognize
that identifying risk factors for deviations in one or more domains may provide
the opportunity to intervene as early as possible and support functioning in
daily life. In the PBC several NFU (Dutch Federation of Academic Medical
Centers) recognized national expertise centers are specifically aimed at
multidisciplinary care-paths, combined with research. For other patient groups,
there is not yet an expertise center they can benefit from. Preliminary
research done by PBC members confirms that parents and caretakers worry about
their child*s ability to grow into an independent adult. Our patients and
parents tell us that they need attention to meaningful outcomes, emotional
wellbeing, and burden of care (Heijdenrijk, 2021) In order to achieve relevant
and meaningful outcomes, it will be necessary to compare test results to *what
is normal". Currently, many pediatric tests cannot be appropriately interpreted
because of using reference intervals derived from either adult population,
hospitalized pediatric populations, or from outdated methodologies.
Age-specific reference intervals are important for interpreting measurements in
the pediatric population but unfortunately, there are very few studies that
provide this information. In the CBL we measure the development of the
participants in different relevant domains in three different rooms. These
include psychological functions (intelligence, emotions, communication, and
behavior) in the cognition room, motor function and growth in the motor room,
and senses and neurophysiology in the sensory room. The SuperSEN study will be
conducted in the sensory room. In the sensory room a multisensory measurement
setup is created to simultaneously generate visual and auditory stimuli to
measure the evoked brain activity using EEG, with respectively eye movement
responses using EyeTracking and Evoked Related Potentials (ERP). Furthermore, a
new EEG cap is being used to measure EEG. In contrast to the traditional use of
separate electrodes, this cap could be less time consuming and more appropriate
to use in children with or without head injuries. In addition, an Optical
Coherence Tomography (OCT) device is present to make detailed retinal scans.
Study objective
Our primary objective is to collect normative reference values in typically
healthy developing children, aged 0 - 18 years, for EEG in combination with ERP
and eyetracking, and OCT measurements (For details see also paragraph 5.1).
Study design
Prospective (cross sectional), single center.
Study burden and risks
The burden of participating in this project is a time investment, i.e. children
must visit the CBL in Erasmus MC Sophia Children's Hospital for approximately
one hour to perform measurements.
The tests are non-invasive and not painful. Children will for example be asked
to do different information processing tasks, wear an EEG cap, and look into an
OCT-machine.
Children, parents and/or caregivers will be informed that measurements are
performed in a research setting. All data is collected for research purposes
only and therefore individual results will not be shared with participants.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
Healthy children aged 0 - 18 years old
Exclusion criteria
* Receives treatment from a (para)medical professional for a neurological
disorder.
* Receives treatment from a (para)medical professional for a psychiatric/mental
health disorder.
* Injury or diagnosis that affect eyesight (high hyperopia (>=+4 D) or high
myopia (<=*2.5 D).
* Injury or diagnosis that affect hearing. * Gestational age < 37 weeks or > 42
weeks
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 | NL88541.078.24 |