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โ† Trials
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Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease

RecruitingNAAges 60 Years - 80 YearsAllXuanwu Hospital, Beijing
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if personalized, multimodal imaging-guided, EEG-based closed-loop Temporal Interference Brain Stimulation (TIBS) can improve memory function in individuals with preclinical Alzheimer's Disease (AD). The main questions it aims to answer are: 1. Does personalized TIBS lead to significant changes in functional connectivity strength of hippocampal-cortical networks at the end of the 2-week intervention compared to baseline? 2. What are the short-term (end of 2-week intervention) and medium-to-long-term (4 weeks and 12 weeks post-intervention) effects of personalized TIBS on episodic and working memory, as well as other cognitive domains in preclinical AD? 3. How does personalized TIBS modulate brain activity and connectivity, as measured by EEG power spectra and functional MRI (fMRI) functional connectivity, in preclinical AD? 4. What is the safe

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals recruited from neurology memory clinics or communities. * Age between 60 and 80 years old, inclusive; no gender limitation. * Right-handed. * Cognitive function test results within normal range after age, gender, and education-level adjustment, OR mild cognitive impairment not yet meeting diagnostic criteria for Mild Cognitive Impairment (MCI), OR only subjective cognitive decline. * Individuals classified as preclinical AD based on the revised 2024 AD diagnostic and staging criteria (i.e., cognitively normal with positive plasma p-tau217 or positive Aฮฒ PET). * Full understanding of the study, voluntary participation, and provision of written informed consent approved by the Ethics Committee. Exclusion Criteria: * Past or present neurological diseases (e.g., stroke, epilepsy, Parkinson's disease, multiple sclerosis). * Psychiatric disorders such as severe depression or severe anxiety. * Systemic diseases causing cognitive decline (e.g., severe thyroid dysfunction, severe liver or kidney disease, severe nutritional deficiencies). * Currently taking medications that may affect cognitive function (e.g., anticholinergics, benzodiazepines, antipsychotics) that cannot be discontinued or adjusted. * Other factors leading to cognitive decline that are not AD-related. * Contraindications for MRI scans, such as claustrophobia, implanted metallic devices (e.g., pacemakers, cochlear implants, aneurysm clips), or history of head injury with retained metal fragments.
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What it tests

  • Active TIBS
  • Sham TIBS
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Where

2 sites
Hainan university
Sanya, China
Xuanwu Hospital of Capital Medical University
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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