- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01720979
TBI Project Amsterdam
Attention, Learning and Behaviour Following Traumatic Brain Injury in Children
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brabant
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Eindhoven - Tilburg, Brabant, Países Bajos
- Libra rehabilitation centers Blixembosch Leijpark
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Noord Holland
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Amsterdam, Noord Holland, Países Bajos, 1081
- Academic Medical Center
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Amsterdam, Noord Holland, Países Bajos, 1081
- VU University of Amsterdam
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Huizen, Noord Holland, Países Bajos, 1081
- Merem revalidatiecentra de Trappenberg
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Zuid Holland
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Rotterdam, Zuid Holland, Países Bajos
- Erasmus MC
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL37226.029.11
Información sobre medicamentos y dispositivos, documentos del estudio
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