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Effectiveness of Computerized Cognitive Training in the Elderly With Cognitive Impairment (CoCoTA)

16 de mayo de 2019 actualizado por: SangYun Kim, Seoul National University Bundang Hospital

Effectiveness of Computerized Cognitive Training Apparatus (CoCoTA) in the Elderly With Normal Cognition, Subjective Cognitive Impairment, Mild Cognitive Impairment

This study is to investigate the effectiveness of computerized cognitive training, and corresponding neural substrates through multimodal neuroimaging assessment, in the elderly with normal cognition, subjective cognitive impairment, and mild cognitive impairment.

Descripción general del estudio

Estado

Terminado

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

Intervencionista

Inscripción (Actual)

26

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

51 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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:
  • CoCoTA
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:
  • CoCoTA
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:
  • CoCoTA

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: SangYun Kim, MD,PhD, Seoul National University Bundang Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2012

Finalización primaria (Actual)

1 de abril de 2013

Finalización del estudio (Actual)

1 de julio de 2013

Fechas de registro del estudio

Enviado por primera vez

22 de junio de 2015

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2015

Publicado por primera vez (Estimar)

24 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

16 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

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. .

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