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Идёт набор NCT05907343

Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline

Без фазы С лечением Mild Cognitive Impairment

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: Sham TBS, Closed-loop TBS, Open-loop TBS.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment. Базовые параметры: 18 лет — 90 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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Обзор

The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in cognitively healthy adults and older adults diagnosed with mild cognitive disorder (MCI). The main questions it aims to answer are: * whether it is possible to restore various cognitive functions in older adults diagnosed with MCI by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and * whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS. Participants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game. Researchers will compare the effects of sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.

Вмешательства

  • Устройство Sham TBS
    A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a sham coil when its output indicates that the participant is not properly engaged in the video game.
  • Устройство Closed-loop TBS
    A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a real coil when its output indicates that the participant is not properly engaged in the video game.
  • Устройство Open-loop TBS
    A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. TBS with the real coil is delivered irrelevant of the BCI decoder output.

Первичные конечные точки

  • Behavioral performance of the video game task [Срок оценки: Up to 1 hour after intervention]
  • Accuracy of the BCI classifier output [Срок оценки: Up to 1 hour after intervention]
  • Cognitive assessment I: Montreal Cognitive Assessment [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment II: Hopkins Adult Reading Test [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment III: Multilingual Naming Test [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment IV: Animal Naming [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment V: Number Span [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment VI: Trail Making Test [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment VII: Southwestern Assessment of Processing Speed [Срок оценки: Up to 8 weeks after intervention]
  • Cognitive assessment VIII: Hopkins Verbal Learning Test-Revised [Срок оценки: Up to 8 weeks after intervention]

Критерии участия

Критерии включения

  • Cognitively normal younger adults
  • Ages between 18 to 35 years
  • Good general health
  • Normal or corrected vision
  • Completed elementary school education or able to understand middle school level experiment instructions
  • Cognitively normal older adults
  • Ages between 60 to 90 years
  • Good general health
  • Normal or corrected vision
  • Completed elementary school education or able to understand middle school level experiment instructions
  • Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment
  • Older adults with mild cognitive impairment (MCI)
  • Ages between 60 to 90 years
  • Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
  • Good general health
  • Normal or corrected vision
  • Completed elementary school education or able to understand middle school level experiment instructions

Критерии исключения

  • Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).
  • Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
  • Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
  • Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
  • Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Health Discovery Building — Austin

Идентификаторы

NCT: NCT05907343 · STUDY00003055

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗