Идёт набор NCT07324161

Efficacy and Safety of Transcranial Magnetic Stimulation in Treatment of Alzheimer's Disease

Без фазы С лечением Alzheimer s 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: rTMS, sham rTMS.
Кому может быть актуально: Состояния в реестре: Alzheimer s Disease. 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: Китай
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

Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in the Treatment of Alzheimer's Disease and Exploration of Glymphatic Mechanisms

Обзор

This study is grounded in the regulatory mechanisms of the glymphatic system and applies repetitive transcranial magnetic stimulation (rTMS) to the treatment of Alzheimer's disease (AD). The clinical efficacy and safety of rTMS will be systematically evaluated. Furthermore, transcranial magnetic stimulation-evoked potentials (TMS-EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to investigate, from the perspectives of synaptic plasticity and neurovascular coupling, the mechanisms by which rTMS influences glymphatic function. Collectively, this work aims to provide new insights into both the therapeutic effectiveness and the underlying mechanisms of rTMS in AD.

Вмешательства

Устройство rTMS
Stimulation coil Cool-B65 A CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week.Consolidation therapy was also administered weekly for 6 months.
Устройство sham rTMS
Stimulation coil Cool-B65 P CO, positioning individualised, stimulation frequency 20Hz, stimulation intensity 100% of motor threshold, stimulation number 40 pulses/train, train interval 28s, 40 trains, 1600 total stimulation pulses, total stimulation time 20 min, treatment application once a day, continuous application for two weeks, 5 days a week

Первичные конечные точки

MoCA Changes from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]

Вторичные конечные точки (5)

CDR Changes from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]
MMSE Changes from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]
NPI Changes from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]
Neuropathological markers Change from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]
TMS-EEG Changes from baseline to post-treatment [Срок оценки: Baseline vs 2 weeks and 6 months after treatment]

Критерии участия

Критерии включения

Meets the 2018 NIA-AA diagnostic criteria for Alzheimer's disease (AD)
Meets DSM-5 diagnostic criteria
Mild to moderate disease severity (CDR Global Score 1 to 2)
Evidence of AD pathology: positive amyloid PET OR positive cerebrospinal fluid (CSF) AD biomarkers OR positive plasma AD biomarkers