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Completed

NCT Number: NCT01720979

TBI Project Amsterdam

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Libra rehabilitation centers Blixembosch Leijpark, Eindhoven - Tilburg, North Brabant, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The white-matter integrity of children with TBI will be compared to children with traumatic control injuries

    Time frame: on average 1-year post-TBI

    FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.

  2. Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries

    Time frame: on average 1-year post-TBI

    Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries

Secondary outcomes

  1. Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries

    Time frame: on average 1-year post-TBI

    Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries

  2. Academic achievement will be compared between children with TBI and children with traumatic control injuries

    Time frame: on average 1-year post-TBI

    Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries

  3. Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries

    Time frame: on average 1-year post-TBI

    Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries

Sponsors and collaborators

Lead sponsor

Marsh Königs

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam UMC, location VUmc

Registry information

Official study title

Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2012
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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