traumatic brain injury
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the TBI group will be: 1. 4-18 years; 2. Fluent Dutch speaker; 3. Inhabitant of The Netherlands; 4. Hospital admission for mild to severe TBI. 5. No documented and/or parent-reported diagnosis of a neurological disorder (other than TBI). Inclusion criteria for the control group will be: 1. 4-18 years; 2. Fluent Dutch speaker; 3. Inhabitant of The Netherlands; 4. No documented and/or parent-reported diagnosis of a neurological disorder (among which TBI).
Exclusion criteria
Exclusion criteria: Participants who meets any of the following criteria will be excluded from participation in this study: 1. Absence or withdrawal of written informed consent; 2. Severe motor disability that interferes with outcome assessment at time of assessment; 3. Inability to comprehend testing instructions at time of assessment; 4. Somatic disorders unrelated to TBI and possibly affecting the outcome assessments at time of assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of the study are motor functioning (Movement-ABC2), neurocognitive functioning (Wechsler Intelligence Test) and behavioral functioning (Child Behavior Checklist and Teacher Report Form), which will be used to construct an overall outcome score. Demographic, pre-injury and clinical predictors will be prospectively registered, as well as outcome at 6 months post-injury. Magnetic resonance imaging (MRI) will be performed at 1 month post-injury in a subsample of the children with TBI (aged >=8 years, n = 150). Outcome will be defined by the level of functioning for the child*s demographics and pre-injury functioning. This will be measured by an overall outcome score that will be constructed in three steps. First, total scores on each test for each outcome domain (motor, neurocognitive and behavioral functioning) will be transformed to z-scores, where the z-score describes the difference between each TBI patient*s score and the mean of the demographically-matched control group. Second, we will further adjust these z-scores for the influence of pre-injury functioning (parent reported pre-injury behavioral functioning and family functioning) by adding these variables as predictors to the linear regression analyses on each z-score pertaining to an outcome domain. The demographic and pre-injury adjusted z-scores will then be retrieved by extracting the standardized residuals of these regression analyses. Lastly, the overall outcome score will be calculated by the sum of the adjusted z-scores. Since children with high pre-injury functioning and significant decrement in functioning can still perform in the average range of the general population, the demographic and pre-injury adjustment procedure will increase sensitivity of outcome prediction. The overall outcome score is used for the sake of clinical usability, enabling the development of one prognostic model for outcome in a range of relevant domains of functioning. Thanks to its cumulative nature, | — |
Secondary
| Measure | Time frame |
|---|---|
| • Health status (TBI group and control group): Health status will be assessed as a reference standard, allowing to investigate the relevance of primary study parameters for health status. We will use the Childhood Health Assessment Questionnaire, measuring heath status as defined by disability in a range of Activities of Daily Life. • School functioning (TBI group and control group): School functioning will be assessed as a secondary outcome measurement in the subsample of children attending a primary school. CITO Pupil Monitoring System results will be used to assess school functioning. Based on the expected age range of this group (6-12 years), this information will be available for a subsample of (3,5*30=) 105 children with TBI. The size of this subsample allows to build a separate highly relevant prediction model for school outcome with a maximum of 7 predictors. • Brain structure and function (TBI group only): Brain structure and function will be assessed in children with TBI in order to investigate the (1) value of innovative MRI for prognostic purposes and (2) neuroanatomical and neurophysiological mechanisms that underlie neurocognitive impairment and daily life problems. Brain structure and function will be measured using MRI sequences. • Specific neurocognitive functioning (TBI group and control group): Specific neurocognitive functioning will be assessed in order to investigate the neurocognitive mechanisms that underlie daily life problems and will be measured using the Emma Toolbox for Computerized Neurocognitive Testing; • Quality of life (TBI group and control group): Quality of life will be measured using the EQ-5D questionnaires for children and adults. • Brain function (TBI and control group): Resting state brain activity in children will be assessed in order to investigate (1) the E-I balance in children following TBI, (2) assess its value towards explaining the heterogeneity in functional outcome. Brain function will be assessed using restin | — |
Countries
Netherlands
Outcome results
None listed