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Набор по приглашению NCT07694921

Effect and Safety of Non-invasive Electrical Stimulation in Alzheimer's Disease

Без фазы С лечением Alzheimer's Disease(AD)

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: Temporal Interference Stimulation.
Кому может быть актуально
Состояния в реестре: Alzheimer's Disease(AD). Базовые параметры: от 60 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

Effect and Safety of Non-invasive Electrical Stimulation in Improving Cognitive and Depressive Symptoms in Alzheimer's Disease

Обзор

Alzheimer's disease (AD) is the most common neurodegenerative disorder, characterized primarily by cognitive impairment as its main clinical symptom, often accompanied by emotional disturbances such as depression and anxiety, imposing a significant disease burden. Temporal Interference Stimulation (TIS) is an emerging non-invasive electrical stimulation technique that precisely targets deep structures within the hippocampus through interference of multiple electric fields. This study will administer a two-week TIS treatment to patients with AD co-occurring depression, targeting the hippocampus, and compare changes in patients' cognitive function, scores on depression and anxiety scales, and functional magnetic resonance imaging (fMRI) data before and after treatment. An emotional word recall task will be administered during fMRI scans. The aim of this study is to investigate the efficacy, safety, and neural mechanisms of TIS-mediated modulation of hippocampal circuits in improving cognitive and emotional functioning in patients with AD and comorbid depression.

Вмешательства

  • Устройство Temporal Interference Stimulation
    During the treatment period, all subjects were treated with a fixed time interference stimulation (TI) device at a frequency of 30 minutes twice a day, 5 days a week, for a total of 10 treatments. The output current intensity during treatment is Individualized.

Первичные конечные точки

  • Alzheimer Disease Assessment Scale-Cognitive(ADAS-Cog) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • The 24-item Hamilton Depression Scale (HAMD-24) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
Вторичные конечные точки (3)
  • Mini-Mental State Examination (MMSE) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Clinical Dementia Rating (CDR) [Срок оценки: From enrollment to the end of treatment at 2 weeks]
  • Hamilton anxiety scale (HAMA) [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Критерии участия

Критерии включения

  • (1) Right-handed, Han ethnicity; (2) Meet the clinical diagnostic criteria for Alzheimer's disease as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); (3) Age ≥60 years, with at least primary school education, and capable of cooperating during testing; (4) Mini-Mental State Examination (MMSE) score <24; (5) Clinical Dementia Rating (CDR) score of 0.5 or 1; (6) The 24-item Hamilton Depression Scale (HAMD-24) score ≥20.

Критерии исключения

  • (1) Systemic diseases causing cognitive impairment, such as hypothyroidism, vitamin B12 or folic acid deficiency, and acquired immunodeficiency syndrome; (2) Comorbid neurological disorders including epilepsy, Parkinson's disease, normal-pressure hydrocephalus, and brain tumors; (3) Comorbid mental illnesses such as schizophrenia, bipolar disorder, or psychiatric disorders due to alcohol or drug abuse; (4) History of post-traumatic loss of consciousness, intracranial infection, or cerebrovascular disease; (5) A Hachinski Ischemic Scale (HIS) score ≥4; (6) Cranial MRI revealing ischemic lesions involving critical brain regions like the hippocampus, thalamus, basal ganglia, or angular gyrus, or multiple ischemic lesions in deep gray matter of the cerebral hemispheres; (7) Inability to undergo MRI due to special conditions such as internal metal implants or pacemakers.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Department of Psychiatry, First Affiliated Hospital of Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07694921 · IIT20250215C-R2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗