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TBI Project Amsterdam

This study is currently recruiting participants.
Verified November 2012 by VU University of Amsterdam
Sponsor:
Collaborators:
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merem revalidatiecentra de Trappenberg
Information provided by (Responsible Party):
Marsh Königs, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01720979
First received: October 25, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.

  • 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 ] [ Designated as safety issue: No ]
    Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries

  • Academic achievement will be compared between children with TBI and children with traumatic control injuries [ Time Frame: on average 1-year post-TBI ] [ Designated as safety issue: No ]
    Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries

  • 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 ] [ Designated as safety issue: No ]
    Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries


Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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 characterised 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, socio-economic status), hospitalisation and the type of injuries other than brain injuries.

Measures:

Neurocognitive tests of attention and learning. Standardised parental and teacher reports of behavioural regulation. Standardised tests of academic achievement. Standardised test of orientation and amnesia.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720979

Contacts
Contact: Marsh Königs, MSc m.konigs@vu.nl

Locations
Netherlands
VU University of Amsterdam Recruiting
Amsterdam, Noord Holland, Netherlands, 1081
Academic Medical Center Recruiting
Amsterdam, Noord Holland, Netherlands, 1081
Merem revalidatiecentra de Trappenberg Recruiting
Huizen, Noord Holland, Netherlands, 1081
Sponsors and Collaborators
Marsh Königs
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Merem revalidatiecentra de Trappenberg
Investigators
Principal Investigator: Jaap Oosterlaan, PhD VU University of Amsterdam
  More Information

No publications provided

Responsible Party: Marsh Königs, MSc, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01720979     History of Changes
Other Study ID Numbers: NL37226.029.11
Study First Received: October 25, 2012
Last Updated: November 1, 2012
Health Authority: The Netherlands: Inspectie voor de Gezondheidszorg

Keywords provided by VU University of Amsterdam:
TBI
Traumatic Brain Injury
Children
Prognosis
Neurocognition

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013