- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01958437
Enhancing Spatial Navigation Using Non-Invasive Brain Stimulation
Remembering how to travel from one location to another is critical in everyday life, yet this vital ability declines with normal aging and can be further affected by conditions that disproportionately affect the elderly, such as vision loss or progressive dementia. Human and animal research has shown that two distinct memory systems interact during navigation. The first, referred to as allocentric navigation, is very flexible and uses spatial knowledge of key features or landmarks to develop and use a mental map of the environment. This approach involves brain regions that are critical for new learning and memory but that decline with age. The second, referred to as egocentric navigation, is inflexible and relies on "habit" memories that link specific features with specific directions. This approach relies on brain regions that are critical for "automatic" responses and that are relatively unaffected by age.
The main problem is that allocentric navigation declines with age and is accompanied increased dependence on egocentric navigation. This change increases the risk of becoming disoriented or "lost" when traveling in unfamiliar areas or even when traveling new routes in familiar areas. Therefore, the main goal of this project is to examine whether non-invasive brain stimulation, specifically transcranial direct current stimulation, can improve allocentric navigation in healthy older adults and patients with mild cognitive impairment.
Participants will complete two functional magnetic resonance imaging sessions while learning new environments. Before one of these sessions, participants will receive active brain stimulation over the parietal cortex. Before the other session, participants will receive sham brain stimulation over the parietal cortex. The effects of this stimulation will be evaluated using both an allocentric and an egocentric memory test. Physiologic effects will be evaluated using both task-based and resting-state MRI.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Georgia
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Decatur, Georgia, Соединенные Штаты, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
General inclusion criteria (all participants):
- All medications stable for approximately 1-2 months;
- No history of severe mental illness;
- No current untreated alcohol or substance abuse/dependence;
- English as native and preferred language;
- MRI-compatible if taking part in fMRI studies
- Able to give informed consent.
MCI Inclusion Criteria:
- Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
Healthy older adults
- intact cognitive functioning as measured by neuropsychological testing
Exclusion Criteria:
- History of neurological disease or injury
- History of severe mental illness
- Current untreated alcohol or substance abuse
- Other conditions may exclude; please discuss with contact
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Cognitively intact older adults - ACTIVE tDCS
Group receives active brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Активный компаратор: MCI ACTIVE tDCS
Group receives active brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Фальшивый компаратор: Cognitively intact older adults - SHAM tDCS
Group receives sham brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Фальшивый компаратор: MCI SHAM tDCS
Group receives sham brain stimulation
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Active and/or sham; All participants receive both stimulation condition.
Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Accuracy in Centimeters From Target Location for Allocentric
Временное ограничение: Outcome assessed after each of 2 sessions (estimated within 1 week of each other)
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1 active tDCS; 1 sham tDCS for each measure.
Participants touched a screen (using a ELO 19" touchscreen monitor) to document the location of the landmark.
The distance between the actual vs. selected location served as the dependent measure.
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Outcome assessed after each of 2 sessions (estimated within 1 week of each other)
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Hippocampal BOLD Signal During Task-based fMRI
Временное ограничение: change between active and sham tDCS sessions (<1month)
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BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS > sham HD-tDCS).
Activation maps thresholded at p<.01 with minimum cluster size of 5 voxels.
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change between active and sham tDCS sessions (<1month)
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Dorsal Attention Network Connectivity During Resting-state fMRI
Временное ограничение: change between active and sham tDCS sessions (<1month)
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Change in resting state functional connectivity strength between active and sham tDCS sessions.
Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.
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change between active and sham tDCS sessions (<1month)
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Egocentric
Временное ограничение: Outcome assessed after each of the 2 sessions
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Number of turns correctly recalled for each egocentric environment
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Outcome assessed after each of the 2 sessions
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Соавторы и исследователи
Следователи
- Главный следователь: Benjamin M Hampstead, PhD, VA Ann Arbor Healthcare System, Ann Arbor, MI
Публикации и полезные ссылки
Общие публикации
- England HB, Fyock C, Meredith Gillis M, Hampstead BM. Transcranial direct current stimulation modulates spatial memory in cognitively intact adults. Behav Brain Res. 2015 Apr 15;283:191-5. doi: 10.1016/j.bbr.2015.01.044. Epub 2015 Jan 31.
- Lengu K, Ryan S, Peltier SJ, Tyszkowski T, Kairys A, Giordani B, Hampstead BM. Effects of High Definition-Transcranial Direct Current Stimulation on Local GABA and Glutamate Levels Among Older Adults with and without Mild Cognitive Impairment: An Exploratory Study. J Alzheimers Dis. 2021;84(3):1091-1102. doi: 10.3233/JAD-201091.
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
- C1381-P
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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. .
Клинические исследования Transcranial direct current stimulation (tDCS)
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Kaohsiung Medical University Chung-Ho Memorial...Завершенный
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Angiodynamics, Inc.ЗавершенныйКарцинома, гепатоцеллюлярнаяФранция, Германия, Италия, Испания