## Protocol Section
### Identification Module
**NCT ID:** NCT01720979

**Brief Title:** TBI Project Amsterdam

**Official Title:** Attention, Learning and Behaviour Following Traumatic Brain Injury in Children

#### Organization Study ID Info
**ID:** NL37226.029.11
#### Organization
**Class:** OTHER
**Full Name:** VU University of Amsterdam
### Status Module
#### Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-12-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-02

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-09

**Type:** ACTUAL

#### Start Date
**Date:** 2011-11

**Status Verified Date:** 2015-12

#### Study First Post Date
**Date:** 2012-11-02
**Type:** ESTIMATED
**Study First Submit Date:** 2012-10-25
**Study First Submit QC Date:** 2012-11-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Amsterdam UMC, location VUmc

**Class:** OTHER

**Name:** Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

#### Lead Sponsor

**Class:** OTHER

**Name:** Marsh Königs

#### Responsible Party

**Investigator Affiliation:** VU University of Amsterdam

**Investigator Full Name:** Marsh Königs

**Investigator Title:** MSc

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Traumatic Brain Injury

**Keywords:**

- TBI

- Traumatic Brain Injury

- Children

- Prognosis

- Neurocognition

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Label:** Patients with traumatic injuries

### Outcomes Module

#### Primary Outcomes

**Description:** FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.

**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

**Description:** Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries

**Measure:** 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

#### Secondary Outcomes

**Description:** Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries

**Measure:** 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

**Description:** Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries

**Measure:** Academic achievement will be compared between children with TBI and children with traumatic control injuries

**Time Frame:** on average 1-year post-TBI

**Description:** Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries

**Measure:** 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

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Children that have been admitted to the hospital after sustaining trauma.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Eindhoven - Tilburg

**Country:** Netherlands

**Facility:** Libra rehabilitation centers Blixembosch Leijpark

**State:** Brabant

**Location 2:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Academic Medical Center

**State:** Noord Holland

**Zip:** 1081

**Location 3:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** VU University of Amsterdam

**State:** Noord Holland

**Zip:** 1081

**Location 4:**

**City:** Huizen

**Country:** Netherlands

**Facility:** Merem revalidatiecentra de Trappenberg

**State:** Noord Holland

**Zip:** 1081

**Location 5:**

**City:** Rotterdam

**Country:** Netherlands

**Facility:** Erasmus MC

**State:** Zuid Holland

#### Overall Officials

**Official 1:**

**Affiliation:** VU University of Amsterdam

**Name:** Jaap Oosterlaan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: HIGH

- As Found: Traumatic Brain Injury

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000070642

- Term: Brain Injuries, Traumatic

### Misc Info Module

- Version Holder: 2024-05-24
