TBI Project Amsterdam

Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• Netherlands
  • Brabant
    • Eindhoven - Tilburg, Brabant, Netherlands
      • Libra rehabilitation centers Blixembosch Leijpark
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1081
      • Academic Medical Center
    • Amsterdam, Noord Holland, Netherlands, 1081
      • VU University of Amsterdam
    • Huizen, Noord Holland, Netherlands, 1081
      • Merem revalidatiecentra de Trappenberg
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children that have been admitted to the hospital after sustaining trauma.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with traumatic injuries; Children that were admitted to the hospital after traumatic injuries to body parts below the clavicles (traumatic control injury) and children that were admitted to the hospital after traumatic brain injury as diagnosed by a physician (TBI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Marsh Königs
• Collaborators: Amsterdam UMC, location VUmc; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: November 1, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 2, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Prognosis; Children; TBI; Traumatic Brain Injury; Neurocognition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: NL37226.029.11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No