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Набор по приглашению NCT05448768

Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI

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: TBS for Amyloid-positive MCI, TBS for Amyloid-negative MCI.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment. Базовые параметры: 50 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
Тайвань
Следующий шаг
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Официальное название

Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)

Обзор

This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).

Подробное описание

The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.

Вмешательства

  • Устройство TBS for Amyloid-positive MCI
    The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.
  • Устройство TBS for Amyloid-negative MCI
    The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.

Первичные конечные точки

  • Mini-Mental State Examination ( MMSE ) [Срок оценки: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS]
  • Montreal Cognitive Assessment [Срок оценки: Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS]
Вторичные конечные точки (1)
  • The standard uptake values changes of FDG-PET [Срок оценки: Before and immediately after TBS intervention]

Критерии участия

Критерии включения

  • Subjects aged 50-90 year
  • Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
  • The CDR of MCI patients can be 0-0.5
  • Amyloid PET should ever be performed

Критерии исключения

  • Any subject has a definite diagnosis of epilepsy or history of seizure attack.
  • Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
  • Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.
  • Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.
  • Any females who is pregnant or lactating.
  • General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.

Withdrawal criteria

  • Complications onset after intervention that affect efficacy and safety judgments.
  • New onset or progression of disease that may affect outcomes.
  • Use of other therapies or drugs during the intervention period to change cognitive functions.
  • Any subjects who are recognized as high risk of adverse effects by principle investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Chang Gung Memorial Hospital — Taoyuan

Идентификаторы

NCT: NCT05448768 · 202102037A3A0

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗