TBI Project Amsterdam

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01720979
• Lead Sponsor: Marsh Königs

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

Academic Medical Center; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

VU University of Amsterdam; 🇳🇱 Amsterdam, Noord Holland, Netherlands

Merem revalidatiecentra de Trappenberg; 🇳🇱 Huizen, Noord Holland, Netherlands

Libra rehabilitation centers Blixembosch Leijpark; 🇳🇱 Eindhoven - Tilburg, Brabant, Netherlands