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Идёт набор NCT07496918

Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)

Фаза II С лечением Cognitively Healthy People Alzheimer Disease

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: GENUS, Tactile GENUS.
Кому может быть актуально
Состояния в реестре: Cognitively Healthy People, Alzheimer Disease. Базовые параметры: 18 лет — 100 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Study to Evaluate Feasibility of Sensory Stimulation With Gamma Frequency Entrainment

Обзор

Despite the huge healthcare and economic impact of AD, there is still no disease modifying therapeutics available. In fact, the available therapeutics show low efficacy at best in the treatment of cognitive impairment in dementia. Development of a non-invasive medical device that is effective in slowing cognitive impairment is not only revolutionary but also possibly cost- effective. In this study, participants will come to MIT for a 1-day visit and the investigators will evaluate the effects of GENUS in cognitively normal, healthy adults. Investigators will use Electroencephalogram (EEG), Magnetoencephalography (MEG), magnetic resonance imaging (MRI), neuropsychological testing, and blood sampling in subsets of participants to evaluate for biological effects and safety of GENUS stimulation.

Подробное описание

Information processing in the brain is thought to occur through synchronized neuronal activity in the form of network oscillations. Activity in the 30-100 Hz range is considered gamma-band oscillation and has been reported to be critical for attention, memory formation, and recall. Disruptions of gamma oscillations, particularly in the 30 - 50 Hz range, are reported as a potential early hallmark of Alzheimer's disease.

40Hz gamma frequency stimulation was previously shown to reduce Alzheimer's disease pathology and improve cognitive outcomes. This study aims to:

1. Determine whether non-invasive 40Hz sensory stimulation (ie, light, sound, tactile) can change brain activity. 2. Evaluate whether devices delivering non-invasive 40Hz sensory stimulation are safe in cognitively normal adults. 3. Determine whether non-invasive 40Hz sensory stimulation can change brain connectivity, neuropsychological measures, blood biomarkers, and the microbiome.

Вмешательства

  • Устройство GENUS
    The device is a light and sound device that delivers light stimulation using light-emitting diodes (LED) and sound stimulation through a speaker, with a centrally-mounted tablet or phone that plays videos for entertainment. The device will be positioned on an easel such that the tablet is eye level with the participant while they are sitting 5 feet away or held in their hands. The active device delivers light and sound at 40Hz rate.
  • Устройство Tactile GENUS
    The device is a wrist worn or hand held device that vibrates or otherwise generates tactile stimulation at specific frequencies.

Первичные конечные точки

  • Effects of GENUS on brain oscillations [Срок оценки: 1 year]
  • Effects of GENUS on brain oscillations [Срок оценки: 1 year]
  • Effects of GENUS on brain oscillations [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Have adequate visual and auditory acuity for visual and auditory stimulation to allow for neuropsychological testing.
  • Be able to comply with neuropsychological testing and other study procedures in opinion of site PI.

Exclusion Criteria: Participants will be screened for the following exclusion criteria including if they

  • History of seizure or medical diagnosis of epilepsy.
  • Have MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
  • Under the discretion of the site investigator, the site investigator feels the subject cannot complete sufficient key study procedures. Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • MIT — Cambridge

Публикации

  • Chan D, Suk HJ, Jackson BL, Milman NP, Stark D, Klerman EB, Kitchener E, Fernandez Avalos VS, de Weck G, Banerjee A, Beach SD, Blanchard J, Stearns C, Boes AD, Uitermarkt B, Gander P, Howard M 3rd, Sternberg EJ, Nieto-Castanon A, Anteraper S, Whitfield-Gabrieli S, Brown EN, Boyden ES, Dickerson BC, Tsai LH. Gamma frequency sensory stimulation in mild probable Alzheimer's dementia patients: Results PMID 36454969

Идентификаторы

NCT: NCT07496918 · 1712179268 · Aging Brain Initiative

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗