Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Gamma auditory stimulation device (active setting), Gamma auditory stimulation device (sham setting).
- Кому может быть актуально
- Состояния в реестре: EEG Brain Oscillations, Alzheimer's Disease (AD) and Related Disorders, Cognitive Dysfunction. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Тайвань
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Development and Validation of an Innovative Gamma Auditory Stimulation System for Older Adults With Cognitive Decline: A Randomized, Double-blind, Placebo-controlled Study (Study 1)
Обзор
Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
Подробное описание
Amyloid-beta (Aβ) aggregation and hyperphosphorylated tau protein tangles are widely recognized as the main pathological features of Alzheimer's disease (AD). Numerous domestic and international studies have demonstrated that 40 Hz gamma visual stimulation can effectively enhance 40 Hz gamma neural oscillations in healthy adults and older adults, improve cognitive performance and memory function in older adults and individuals with AD, and has shown good safety with no severe adverse effects.
Nevertheless, there are still several limitations to using 40 Hz visual stimulation as an intervention. Extended exposure to light sources may cause discomfort, affecting participants' willingness to continue. Prolonged light exposure may also increase the risk of seizures in photosensitive individuals. In addition, participants are required to actively fixate on the light source, which may reduce intervention adherence. Most importantly, the ecological validity of light-based stimulation remains low. Many studies require participants to gaze at light for at least five minutes or more, and daily sessions of up to an hour over several months are challenging to implement in daily life. To address these limitations, this project proposes using 40 Hz auditory stimulation as a more practical and sustainable intervention.
Moreover, animal studies have confirmed that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, evidence on the independent application of 40 Hz auditory stimulation in humans remains limited. Therefore, this project will adopt a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
Вмешательства
- Устройство Gamma auditory stimulation device (active setting)
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours. - Устройство Gamma auditory stimulation device (sham setting)
Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours.
Первичные конечные точки
- Changes in neurophysiological function. [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
Вторичные конечные точки (12)
- Change score of the Chinese version Verbal Learning Test (CVVLT). [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the WMS-III logical memory test [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the Taylor Complex Figure Test (TCFT). [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the Cognitive Abilities Screening Instrument (CASI). [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the category Verbal Fluency Test (VFT). [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Performance changes of the Trail Making Test Form A/B (TMT-A/B) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Performance changes of the Digit Span Test [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the neuropsychiatric Inventory (NPI) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the Geriatric Depression Scale -short form (GDS-S) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
- Change score of the 5-level EuroQol-5 Dimension (EQ-5D-5L) [Срок оценки: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
Критерии участия
Критерии включения
- Age over 60 years old.
- MMSE≤ 24
- CDR scores of 0.5 and 1
- Voluntary to sign the Informed Consent Form.
Критерии исключения
- Diagnosis of other psychiatric or neurological disorders
- Drug or alcohol addictions.
- Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
- History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Тайвань · 1 центр
- Chang Gung University — Taoyuan
Идентификаторы
NCT: NCT07087951 · 202402079B0A3