Objectives: 1) Create shared and disease-specific developmental curves with relevant and meaningful outcomes in children with brain-related disorders. 2) Develop innovative paradigms and parameters from neurophysiological, brain structure and motor…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hersengerelateerde aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: In the Child Brain Lab (CBL) we measure
development of the participants on different relevant domains. These include
psychological functions (intelligence, emotions, communication and behaviour),
motor function, growth, senses and neurophysiology. Data will be analysed per
disorder and cross-disorder. We aim at inviting participants for 5 repeated
assessments between 0 and 18 years of age; in case a diagnosis is made at a
later age this may be less, and in specific disorders subtest may be done more
often. The design of the Self-Portrait and the effect on patient/family
satisfaction, participation and shared decision making will be analysed
Secondary outcome
see primary
Background summary
Rationale: The Pediatric Brain Center (PBC) is a collaboration of medical
professionals and researchers in the Sophia Children*s Hospital that are
involved in the clinical care for and research in children with conditions of
the brain, nerves, senses and limbs. To improve patient and family
participation, quality of care (now and in the future) and facilitate research
and trials, we established the Child Brain Lab. The CBL is a function lab that
will allow us to do standardized follow-up in relevant and meaningful domains.
Study objective
Objectives:
1) Create shared and disease-specific developmental curves with relevant and
meaningful outcomes in children with brain-related disorders.
2) Develop innovative paradigms and parameters from neurophysiological, brain
structure and motor measurements.
3) Use advanced data-analyses/statistical techniques and AI to identify early
biomarkers that predict long term development
4) Boost patient engagement by embedding the data acquired in the Child Brain
Lab in a life course and personalised-medicine framework for use in patient
care and to support outcome-based care and shared decision-making (SDM) with
the Self-Portrait.
Study design
Study design: Prospective cohort study
Study burden and risks
The burden of participating in the CBL test circuit is a time investment of 0.5
to 1 day, depending on the child*s age and developmental level. The tests are
non-invasive and not painful. Children will e.g. be asked to do different
information processing tasks, wear an EEG cap, look into the OCT machine, and
walk on an walkway with sensors. Details are found in paragraph 8. Benefit for
the participating families is that they will get a concise version of the
results of the tests of their child in a Self-Portrait, an application we will
develop to support outcome-based healthcare and shared decision making.
Families can use the Self-Portrait in the next consultation with their
specialist to discuss the development of their child. If results give rise to
concern, further treatment will be offered in the PBC or by referral to the
appropriate professional. The CBL is inherently group related, both as we aim
to improve patient care and participation of our patient group as to generate
natural history data on our patient groups.
Dr Molenwaterplein 6-
Rotterdam 3029GD
NL
Dr Molenwaterplein 6-
Rotterdam 3029GD
NL
Listed location countries
Age
Inclusion criteria
Patients with disorders of brain, limbs and senses that are seen more than once
at the outpatient clinic of the pediatric brain center, aged 0-18 years of age,
able to return for long-term follow-up
Exclusion criteria
Patients who are unable to comply with the test circuit at the discretion of
the treating physician
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 | NL82466.078.22 |