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Traumatic Brain Injury | TBI Project Amsterdam

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Patients with traumatic injuriesChildren 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).

Study Status

Completed

Start Date: November 2011

Completed Date: September 2015

Phase:

Type: Observational

Design:

Primary Outcome: The white-matter integrity of children with TBI will be compared to children with traumatic control injuries

Secondary Outcome: Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries

Study sponsors, principal investigator, and references

Principal Investigator: Jaap Oosterlaan, PhD

Lead Sponsor: Marsh Königs

Collaborator: VU University Medical Center

More information:https://clinicaltrials.gov/show/NCT01720979

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