Traumatic Brain InjuryNCT01720979
TBI Project Amsterdam
An observational study of Traumatic Brain Injury, run by Marsh Königs at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 90 participants
- Where
- 5 sitesNetherlands
- Study dates
- Nov 2011to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children that have been admitted to the hospital after sustaining trauma.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
Academic Medical Center
Amsterdam, North Holland, 1081
VU University of Amsterdam
Amsterdam, North Holland, 1081
Libra rehabilitation centers Blixembosch Leijpark
Eindhoven - Tilburg, North Brabant
Merem revalidatiecentra de Trappenberg
Huizen, North Holland, 1081
Erasmus MC
Rotterdam, South Holland
About this study
Official title: Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Traumatic Brain Injury, Children, Prognosis, Neurocognition
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.
Measured: on average 1-year post-TBI
Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries
Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries
Measured: on average 1-year post-TBI
Secondary outcomes (3)
Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries
Measured: on average 1-year post-TBI
Academic achievement will be compared between children with TBI and children with traumatic control injuries
Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries
Measured: on average 1-year post-TBI
Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries
Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries
Measured: on average 1-year post-TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marsh Königs
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Sponsor-investigator, Marsh Königs, VU University of Amsterdam
- Investigators
- Jaap Oosterlaan, PhD, Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720979
- Sponsor's protocol ID
- NL37226.029.11
- Status last verified
- Dec 2015
- First submitted
- 25 Oct 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
- ClinicalTrials.gov ID
- NCT01720979
- Acronym / sponsor ID
- NL37226.029.11
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Traumatic Brain Injury, Children, Prognosis, Neurocognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marsh KönigsUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Nov 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children that have been admitted to the hospital after sustaining trauma.
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
3 secondary outcomes
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
Academic achievement will be compared between children with TBI and children with traumatic control injuries
Time frame: on average 1-year post-TBI
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Traumatic Brain Injury
RecruitingPhase 3
Efficacy of Propranolol in Traumatic Brain Injury Patients Admitted to the ICU: A Prospective, Randomized, Triple-Blind Study
Traumatic Brain Injury (TBI) Patients
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
RecruitingObservational study
Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH)
Subdural Hematoma, Subdural Hematoma, Chronic
Recruiting
Feasibility and Acceptability of an LLM-based Chatbot for Family Caregivers: Evaluation Study
Caregivers
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Oosterlaan, PhD principal investigator
VU University of Amsterdam
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Marsh Königs at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.