- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01720979
TBI Project Amsterdam
Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Brabant
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Eindhoven - Tilburg, Brabant, Holanda
- Libra rehabilitation centers Blixembosch Leijpark
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Noord Holland
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Amsterdam, Noord Holland, Holanda, 1081
- Academic Medical Center
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Amsterdam, Noord Holland, Holanda, 1081
- VU University of Amsterdam
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Huizen, Noord Holland, Holanda, 1081
- Merem revalidatiecentra de Trappenberg
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Zuid Holland
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Rotterdam, Zuid Holland, Holanda
- Erasmus MC
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
Prazo: on average 1-year post-TBI
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FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.
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on average 1-year post-TBI
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Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries
Prazo: on average 1-year post-TBI
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Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries
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on average 1-year post-TBI
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
Prazo: on average 1-year post-TBI
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Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries
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on average 1-year post-TBI
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Academic achievement will be compared between children with TBI and children with traumatic control injuries
Prazo: on average 1-year post-TBI
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Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries
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on average 1-year post-TBI
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Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries
Prazo: on average 1-year post-TBI
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Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries
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on average 1-year post-TBI
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL37226.029.11
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