Clinical trial NCT01720979: TBI Project Amsterdam
Official title: Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: TBI
Traumatic Brain Injury
Children
Prognosis
Neurocognition
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2012-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children that have been admitted to the hospital after sustaining trauma.

Brief summary: Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature suggests a pivotal role for attentional functioning in neurocognitive and behavioural consequences of paediatric TBI. Limitations of traditional neuropsychological measures of attentional functioning have interfered with identification of the effect of paediatric TBI on attentional networks so far. Moreover, the associations between attentional networks, learning abilities, academic performance and behavioural and emotional problems following paediatric TBI are yet to be explored.

Detailed description: Background:

Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade, 1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson, 2001). Literature shows that age at injury is inversely related to the magnitude of deficits following TBI, highlighting the vulnerability of children for the effects of TBI.

The neurocognitive consequences of paediatric TBI have primarily been characterized by impairments in speed of information processing, attentional functioning and learning (Babikian \& Asarnow, 2009; Catroppa \& Anderson, 2009), interfering with typical neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive function and investigate the relations between neurocognitive deficits, academic achievement and emotional and behavioural function, in order to improve our understanding of the post-injury functioning of children that have suffered TBI.

Methods:

Patients with TBI will be compared to a control group consisting of orthopedically injured patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than typically developing children by controlling for TBI risk factors related to neurocognition (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and the type of injuries other than brain injuries.

Measures:

Child's Orientation and Amnesia Test, Attention Network Test, Probabilistic Learning Test, Child Behaviour Checklist, Strengths \& Difficulties Questionnaire, Experimental Neurocognitive Test developed at the VU University and Pupil Monitoring System.

Eligibility criteria: Inclusion Criteria:

TBI patients will be included if they

* have parental written informed consent
* provide written informed consent if aged over 11 years
* are Dutch speaking
* have a clinical diagnosis of TBI (closed head injury)
* have a time post-injury that is longer than 1 month
* are aged between 6-12 years.

Trauma control patients will be included if they:

* have parental written informed consent
* provide written consent if aged over 11 years
* are Dutch speaking
* have suffered an orthopaedic injury
* have no history of TBI
* and are aged between 6-12 years.

Primary outcomes:
measure: The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
timeFrame: on average 1-year post-TBI
measure: Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries
timeFrame: on average 1-year post-TBI
Secondary outcomes:
measure: Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
timeFrame: on average 1-year post-TBI
measure: Academic achievement will be compared between children with TBI and children with traumatic control injuries
timeFrame: on average 1-year post-TBI
measure: Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries
timeFrame: on average 1-year post-TBI
Other outcomes:
Locations:
city: Eindhoven - Tilburg
country: Netherlands
facility: Libra rehabilitation centers Blixembosch Leijpark
state: Brabant
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: VU University of Amsterdam
state: Noord Holland
city: Huizen
country: Netherlands
facility: Merem revalidatiecentra de Trappenberg
state: Noord Holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid Holland
Study officials:
affiliation: VU University of Amsterdam
name: Jaap Oosterlaan, PhD
role: PRINCIPAL_INVESTIGATOR
References: