- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
|
|
Экспериментальный: 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.
Другие имена:
|
|
Активный компаратор: 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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Clinical improvement in the follow-up neuropsychological tests
Временное ограничение: 12 weeks
|
changes in memory and frontal domain subscores between the baseline and follow-up
|
12 weeks
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cortical thickness changes between baseline and follow-up volumetric MRI
Временное ограничение: 12 weeks
|
surface-based morphometry using freesurfer software
|
12 weeks
|
|
White matter integrities changes between baseline and follow-up diffusion tensor imaging
Временное ограничение: 12 weeks
|
tract-based spatial statistics using fsl software
|
12 weeks
|
|
Spectral ratio changes between baseline and follow-up EEG
Временное ограничение: 12 weeks
|
EEG spectral ratio analysis
|
12 weeks
|
|
local activation pattern changes between baseline and follow-up Fludeoxyglucose PET
Временное ограничение: 12 weeks
|
local activation pattern analysis using SPM
|
12 weeks
|
Соавторы и исследователи
Следователи
- Главный следователь: SangYun Kim, MD,PhD, Seoul National University Bundang Hospital
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 10035434
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .