- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01720979
TBI Project Amsterdam
Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Lokalizacje studiów
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Brabant
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Eindhoven - Tilburg, Brabant, Holandia
- Libra rehabilitation centers Blixembosch Leijpark
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Noord Holland
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Amsterdam, Noord Holland, Holandia, 1081
- Academic Medical Center
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Amsterdam, Noord Holland, Holandia, 1081
- VU University of Amsterdam
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Huizen, Noord Holland, Holandia, 1081
- Merem revalidatiecentra de Trappenberg
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Zuid Holland
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Rotterdam, Zuid Holland, Holandia
- Erasmus MC
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Z mocą wsteczną
Kohorty i interwencje
Grupa / Kohorta |
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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).
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
Ramy czasowe: 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.
|
on average 1-year post-TBI
|
Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries
Ramy czasowe: on average 1-year post-TBI
|
Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries
|
on average 1-year post-TBI
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
Ramy czasowe: 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
|
on average 1-year post-TBI
|
Academic achievement will be compared between children with TBI and children with traumatic control injuries
Ramy czasowe: 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
|
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
Ramy czasowe: 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
|
on average 1-year post-TBI
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NL37226.029.11
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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