TBI Project Amsterdam

Sponsor

Marsh Königs (Other)

Overall Status

Completed

CT.gov ID

NCT01720979

Collaborator

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

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

The white-matter integrity of children with TBI will be compared to children with traumatic control injuries [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.
Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries [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 Outcome Measures

Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries [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
Academic achievement will be compared between children with TBI and children with traumatic control injuries [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
Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Libra rehabilitation centers Blixembosch Leijpark	Eindhoven - Tilburg	Brabant	Netherlands
2	Academic Medical Center	Amsterdam	Noord Holland	Netherlands	1081
3	VU University of Amsterdam	Amsterdam	Noord Holland	Netherlands	1081
4	Merem revalidatiecentra de Trappenberg	Huizen	Noord Holland	Netherlands	1081
5	Erasmus MC	Rotterdam	Zuid Holland	Netherlands