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Идёт набор NCT07560904

Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory

Без фазы С лечением Older Adults (60 - 85 Years Old) Mild Cognitive Impairment (MCI)

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: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz), Control striatal stimulation, Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz).
Кому может быть актуально
Состояния в реестре: Older Adults (60 - 85 Years Old), Mild Cognitive Impairment (MCI). Базовые параметры: 60 лет — 80 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
Чехия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

A study investigating the effects of non-invasive electrical stimulation of deep brain structures on working memory, attention, and executive functions involved in everyday activities. Currently, there is no effective treatment for impairments in these functions. The study will evaluate the effects of non-invasive electrical stimulation in both healthy older adults and individuals with mild impairment of these functions. The study combines magnetic resonance imaging (MRI) with non-invasive brain stimulation targeting deep brain structures. Its aim is to improve understanding of the neural mechanisms underlying these cognitive functions and their impairments, as well as to explore the mechanisms of non-invasive brain stimulation for potential future therapeutic applications.

Вмешательства

  • Другое Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz)
    Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (20 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
  • Другое Control striatal stimulation
    A high-frequency tES without low-frequency offset. It will consist of two oscillatory high-frequency currents without any frequency shifts, which induces similar skin sensations as deep-tES and will be applied just for a ramp-up/ramp-down phases at the beginning of the stimulation and afterwards will be switched off.
  • Другое Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)
    Striatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (60 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).

Первичные конечные точки

  • The neural underpinning of NIBS-induced changes quantified by task-fMRI activations [Срок оценки: During intervention ( approximately 10 minutes)]
  • The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches. [Срок оценки: During intervention ( approximately 10 minutes)]
Вторичные конечные точки (2)
  • Working memory performance - Reaction times [Срок оценки: During intervention (approx 10 minutes)]
  • Working memory parformance - Accuracy [Срок оценки: During intervention ( approximately 10 minutes)]

Критерии участия

Критерии включения

  • normal cognitive performance as assessed by a cognitive screening for healthy subjects
  • possible or probable MCI-LB or with PD-MCI, collectively called MCI-LBD, described as: presence of PD , and level II criteria for MCI (i.e. based on comprehensive neuropsychological examination), or the level II criteria for MCI , and at least two of four core DLB features including parkinsonism, visual hallucinations, attention/cognitive function fluctuation, and REM sleep behavioral disorder, or at least 1 core clinical feature and 1 indicative biomarker (probable MCI-LB).

Критерии исключения

  • Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.

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
Фундаментальное исследование

Центры проведения

Чехия · 1 центр
  • CEITEC Masaryk University — Brno

Идентификаторы

NCT: NCT07560904 · NW25-04-00142

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗