- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02480738
Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment (CoCoTA)
Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Computerized cognitive training has the advantage of easy accessibility for community-dwelling elderly. It can be much cheaper than traditional neuropsychological training methods, which require trained neuropsychologists. Furthermore, it may be more fun and easier to be optimized to an individual patients' cognitive status than other traditional methods.
Clinical efficacy of these kinds of cognitive training applications has been validated through several studies. A recent systematic review reported that the domains of working memory, executive function, and processing speed benefited the most by classic computerized cognitive training tasks, and that these benefits were comparable with traditional cognitive training methods. Apart from neuropsychological data, neuroimaging studies focusing on the effectiveness of computerized cognitive training are scant.
There have been no previous studies investigating the possible neural substrates of computerized cognitive training using multimodal neuroimaging modalities simultaneously. Thus, we aimed to investigate the effectiveness of computerized cognitive training and corresponding neural substrates in subjects with mild cognitive impairment, subjective memory impairment, and normal controls through a multimodal approach.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Ages >50 to ≤70
- Years of education ≥ 6 years
- No physical barrier preventing the dominant hand from using the computer mouse
Exclusion Criteria:
- Subjects who had any structural lesions or psychiatric disorders that explained the memory deficits
- Subjects had to be able to undergo pre- and post-training evaluations such as electroencephalography (EEG), FDG-PET, and magnetic resonance imaging (MRI)
- Subjects who had scalp lesions, severe back pain, or claustrophobia that precluded pre- and post-training evaluations.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Mild cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
|
CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia. Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.
Otros nombres:
|
Experimental: Subjective cognitive impairment
Intervention: Computerized Cognitive Training Apparatus
|
CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia. Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.
Otros nombres:
|
Comparador activo: Normal controls
Intervention: Computerized Cognitive Training Apparatus
|
CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia. Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Clinical improvement in the follow-up neuropsychological tests
Periodo de tiempo: 12 weeks
|
changes in memory and frontal domain subscores between the baseline and follow-up
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cortical thickness changes between baseline and follow-up volumetric MRI
Periodo de tiempo: 12 weeks
|
surface-based morphometry using freesurfer software
|
12 weeks
|
White matter integrities changes between baseline and follow-up diffusion tensor imaging
Periodo de tiempo: 12 weeks
|
tract-based spatial statistics using fsl software
|
12 weeks
|
Spectral ratio changes between baseline and follow-up EEG
Periodo de tiempo: 12 weeks
|
EEG spectral ratio analysis
|
12 weeks
|
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
Periodo de tiempo: 12 weeks
|
local activation pattern analysis using SPM
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: SangYun Kim, MD,PhD, Seoul National University Bundang Hospital
Publicaciones y enlaces útiles
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
- 10035434
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .