TBI Project Amsterdam

Traumatic Brain Injury Clinical Trial

Official title:

Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720979
• Other study ID #: NL37226.029.11
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: December 2, 2015
• Start date: November 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Netherlands: Inspectie voor de Gezondheidszorg
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord Holland
Netherlands	VU University of Amsterdam	Amsterdam	Noord Holland
Netherlands	Libra rehabilitation centers Blixembosch Leijpark	Eindhoven - Tilburg	Brabant
Netherlands	Merem revalidatiecentra de Trappenberg	Huizen	Noord Holland
Netherlands	Erasmus MC	Rotterdam	Zuid Holland

Sponsors (3)

Lead Sponsor	Collaborator
Marsh Königs	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The white-matter integrity of children with TBI will be compared to children with traumatic control injuries	FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.	on average 1-year post-TBI	No
Primary	Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries	Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries	on average 1-year post-TBI	No
Secondary	Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries	Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries	on average 1-year post-TBI	No
Secondary	Academic achievement will be compared between children with TBI and children with traumatic control injuries	Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries	on average 1-year post-TBI	No
Secondary	Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries	Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries	on average 1-year post-TBI	No