- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01743417
Computerized Cognitive Rehabilitation in Children After Severe Malaria (CM_CCRT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Our Fogarty "Brain Disorders" R21 study findings demonstrated that attention and working memory deficits persist in one out of four children with cerebral malaria (CM) (Boivin et al., 2007; John, Bangirana et al., 2008). Uganda has one of the highest incidences of malaria worldwide (~480/1000) with about 10% of these incidents becoming severe and over 90% of such cases occurring in children (Snow, Guerra, Noor, Myint, & Hay, 2005). This results in an estimated 80 thousand new cases each year of Ugandan children with mild to severe neurocognitive impairment from this disease. Such impairment will likely compromise their school performance, impede their activities of daily living, and lessen their future economic opportunities.
There is no known treatment intervention during acute illness to prevent CM brain-injury effects (Abubakar et al., 2007). Nor are neurocognitive rehabilitative treatment programs available in low-resource settings for affected children. However, we have successfully piloted a computerized cognitive rehabilitation therapy (CCRT) intervention to specifically improve attention, visual-spatial learning, and psychosocial adjustment (domains shown most affected by CM in our previous studies) with school-age Ugandan CM survivors (Bangirana, Giordani et al., 2009). This evidence justifies an R01 for further study.
The present application proposes a randomized control trial (RCT) to further establish that CCRT can improve attention, working memory, aspects of executive functioning, and psychosocial adjustment in pediatric CM survivors. Such programs are already being used extensively with children with developmental disabilities (e.g., Attention Deficit Hyperactivity Disorder, learning disorders) and brain injury in high-income countries. The evidence from RCT studies for these interventions is strong enough to warrant the evaluation of CCRT for at-risk African children (Bangirana, Idro, John, & Boivin, 2006; Boivin & Giordani, 2009). CCRT could also then be extended to a variety of other infectious diseases causing brain injury and persisting neurocognitive deficits to children in this setting (e.g., HIV, schistosomiasis, meningitis, encephalitis, and neurocysticercosis).
Objectives:
- To evaluate the effectiveness of CCRT in improving neuropsychological performance and psychiatric outcomes in Ugandan children who survive severe malaria.
- To evaluate whether severity of malaria illness (e.g., immunological brain inflammation, EEG abnormalities) is predictive of neuropsychological benefit from CCRT.
- METHODS
Study design:
Randomized controlled trial
Study Population:
Our proposed study groups of children aged 5 to 12 years will consist of 150 children with severe malaria (either cerebral malaria or severe malaria anemia). From the homes of these severe malaria children, we will also recruit 1 sibling (or neighbor child) 5 to 12 years of age without a history of cerebral malaria or other known infectious disease that could cause brain injury (Community Controls from Home: CC children N = 150).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kampala, Uganda
- Makerere University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 5 to 12 years of age;
- Signed consent from the parent/guardian, assent from children aged 7 years and older;
- Completion of their 24 months testing in the parent study (MUREC no 2008-033).
Exclusion Criteria:
- CM: elevated cerebrospinal fluid protein, white blood cells or red blood cells
Severe malarial anemia: history of coma, impaired consciousness, repeated seizures, other brain disorder, and developmental delay. Additional exclusion criteria for CC group:
- any active illness; recent illness or recovery from illness;
- chronic illness requiring medical care; -) medical abnormalities on screening history or physical exam.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cognitive intervention
Children in this arm will receive computerised cognitive rehabilitation training for 24 sessions lasting 45 minutes.
The Captain's log brain training software is programmed to increase in difficulty as child progresses through the training levels.
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24 sessions of computerised bran training will be provided for 8 weeks (+/-2) with about 3 sessions per week to the intervention arm and active control arms.
The program will be programmed to increases in difficulty for the intervention arm.
In the active control arms, the difficulty level will not change.
Otros nombres:
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Comparador activo: Active control
Children in this arm will receive 24 sessions of computerised cognitive rehabilitation training.
Captain's log, the brain training software will not be programmed to increase in difficulty with each successive level in this arm.
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24 sessions of computerised bran training will be provided for 8 weeks (+/-2) with about 3 sessions per week to the intervention arm and active control arms.
The program will be programmed to increases in difficulty for the intervention arm.
In the active control arms, the difficulty level will not change.
Otros nombres:
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Sin intervención: Passive control
No computer training or games will be provided to this group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Executive attention
Periodo de tiempo: Measured at 12 months post-intervention
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Executive attention will be measured by the Test of Variables of Attention
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Measured at 12 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Working memory
Periodo de tiempo: Measured at 12 months post-intervention
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Working memory will be measured by the Kaufman Assessment Battery for Children second edition
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Measured at 12 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael J Boivin, PhD, Michigan State University
- Investigador principal: Noeline Nakasujja, PhD, Makerere University
Publicaciones y enlaces útiles
Publicaciones Generales
- Bangirana P, Allebeck P, Boivin MJ, John CC, Page C, Ehnvall A, Musisi S. Cognition, behaviour and academic skills after cognitive rehabilitation in Ugandan children surviving severe malaria: a randomised trial. BMC Neurol. 2011 Aug 4;11:96. doi: 10.1186/1471-2377-11-96.
- Bangirana P, Giordani B, John CC, Page C, Opoka RO, Boivin MJ. Immediate neuropsychological and behavioral benefits of computerized cognitive rehabilitation in Ugandan pediatric cerebral malaria survivors. J Dev Behav Pediatr. 2009 Aug;30(4):310-8. doi: 10.1097/DBP.0b013e3181b0f01b.
- John CC, Bangirana P, Byarugaba J, Opoka RO, Idro R, Jurek AM, Wu B, Boivin MJ. Cerebral malaria in children is associated with long-term cognitive impairment. Pediatrics. 2008 Jul;122(1):e92-9. doi: 10.1542/peds.2007-3709. Epub 2008 Jun 9.
- Boivin MJ, Nakasujja N, Sikorskii A, Opoka RO, Giordani B. A Randomized Controlled Trial to Evaluate if Computerized Cognitive Rehabilitation Improves Neurocognition in Ugandan Children with HIV. AIDS Res Hum Retroviruses. 2016 Aug;32(8):743-55. doi: 10.1089/AID.2016.0026. Epub 2016 May 2.
- Boivin MJ, Kakooza AM, Warf BC, Davidson LL, Grigorenko EL. Reducing neurodevelopmental disorders and disability through research and interventions. Nature. 2015 Nov 19;527(7578):S155-60. doi: 10.1038/nature16029.
- Boivin MJ, Sikorskii A, Nakasujja N, Ruisenor-Escudero H, Familiar-Lopez I, Opoka RO, Giordani B. Evaluating Immunopathogenic Biomarkers During Severe Malaria Illness as Modifiers of the Neuropsychologic Benefits of Computer Cognitive Games Rehabilitation in Ugandan Children. Pediatr Infect Dis J. 2019 Aug;38(8):840-848. doi: 10.1097/INF.0000000000002367.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 1R01HD064416-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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