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Идёт набор NCT06956300

TMS for Cognitive Decline in Aging and Preclinical AD

Без фазы С лечением Prodromal Alzheimer's Disease Preclinical Alzheimer's Disease Healthy Aging Cognitive Decline

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: Active rTMS, Sham rTMS.
Кому может быть актуально
Состояния в реестре: Prodromal Alzheimer's Disease, Preclinical Alzheimer's Disease, Healthy Aging, Cognitive Decline. Базовые параметры: 40 лет — 99 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
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Официальное название

Grit Against Cognitive Decline in Aging and Preclinical Alzheimer's Disease

Обзор

In this research study we want to learn more about the effects of non-invasive brain stimulation on motivation, memory, and brain-network function in cognitively unimpaired older adults and individuals with preclinical Alzheimer's disease. This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls cognition. Changes resulting from this stimulation will be measured with behavioral tests, as well as by taking brain images with Magnetic Resonance Imaging (MRI). Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.

Вмешательства

  • Устройство Active rTMS
    All study participants will receive one block of ACTIVE rTMS. Each block will consist of daily sessions of active rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).
  • Устройство Sham rTMS
    All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of SHAM rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).

Первичные конечные точки

  • Changes in motivation [Срок оценки: Baseline and post-treatment Day 11]
  • Changes in Brain Network Connectivity [Срок оценки: Baseline and post-treatment Day 11]
  • Changes in Memory [Срок оценки: Baseline and Post-Treatment Day 11]

Критерии участия

Критерии включения

  • Between the ages of 40-99
  • Native English speakers
  • Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
  • Cognitively normal older adults and individuals with preclinical Alzheimer's disease will be included.

Критерии исключения

  • History of head trauma involving loss of consciousness or alteration in consciousness
  • Another major neurologic or psychiatric condition
  • Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
  • Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
  • Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
  • Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
  • Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
  • History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.).
  • Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder.
  • Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT06956300 · 2023A009489

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗