The primary objective is (1) to establish the feasibility of using these neurocognitive tasks in children, and (2) to establish intra-individual variance of task results upon test repetition.The secondary objective is to assess how children have…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
De gebruikte neurocognitieve testen zijn bruikbaar als biomarker voor centrale effecten van geneesmiddelen in bredere zin. Bij deze pilot is er geen sprake van een specifieke aandoening die bestudeerd wordt.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Results of Neurocognitive tasks:
- Stroop color-word task
- Adaptive tracking
- Smooth eye pursuit
- Saccadic Eye movements
- Finger tapping
- Body sway
Results of a short questionnaire taken after completion of the Neurocognitive
tasks.
Secondary outcome
NA
Background summary
Neurocognitive tasks are frequently employed in scientific research. Task
results can be used as correlates of disease state, are often used by
neuropsychologists to elucidate the pathogenesis of neuropsychologic disorders
and can serve as biomarker of drug effects.
Development and use of such biomarkers in pediatric populations lags behind
when compared to the adult population. The need for validated biomarkers in
pediatric drug research is substantial in the light of an expected
intensification of pediatric drug research following the adoption of EU
regulation No. 1901/2006.
The Centre for Human Drug Research (Leiden, the Netherlands) has extensive
experience with a test battery called the Neurocart. The Neurocart consists of
a selected set of neurocognitive tasks, the results of which are used as a
biomarker cq trial endpoint in early phase drug research in adults. It is
reasonable to expect that tasks incorporated in this test battery are also
suited for use in the pediatric population to detect drug effects and/or
discriminate between disease states.
Study objective
The primary objective is (1) to establish the feasibility of using these
neurocognitive tasks in children, and (2) to establish intra-individual
variance of task results upon test repetition.
The secondary objective is to assess how children have experienced trial
participation.
Study design
Observational cohort study
Study burden and risks
This study does not entail any known risks.
The burden imposed by the study is mainly the time investment needed for travel
and test performance. Study occasions will be planned in such a way, that they
do not interfere with school attendance. One of the tasks involves the
application of 3 electrodes in order to measure eye movements. These electrodes
are comparable to ecg stickers, and application or removal is not painful.
In our opinion the study meets the legal requirement of negligible risk and
minimal burden.
There is no benefit associated with study participation (i.e. non-therapeutic
study)
The proposed study can only be performed in the group of paediatric patients as
described above. Performing this study in an adult population would yield major
difficulties since results on neurocognitive tasks can be expected to develop
with age. This phenomenon was demonstrated in a developmental study of
visuospatial attention. In addition, we want to establish how children have
experienced study participation. The study objectives thus cannot be met by
performing the study in legally competent adults.
Zernikedreef 10
2333 CL Leiden
Nederland
Zernikedreef 10
2333 CL Leiden
Nederland
Listed location countries
Age
Inclusion criteria
•Age 8-12 years
•Written informed consent from parents having parental responsibility or from the legal guardian. In the case of a child aged 12 years or older the written informed consent of the child is needed in addition to that of parents having responsibility/legal guardian, in the case of a child aged younger than 12 years, assent needs to be provided.
Exclusion criteria
•Any known psychiatric diagnosis (e.g. autism, oppositional defiant disorder, ADHD)
•Dyslexia
•Learning disability
•Significant behavioural problems
•Use of medication
•Preterm birth
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 | NL19763.058.07 |