Actively Recruiting
Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease
Led by Xuanwu Hospital, Beijing · Updated on 2025-08-15
1200
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 safety profile of personalized TIBS in this population? Researchers will compare participants receiving active personalized TIBS to participants receiving sham (inactive) stimulation to see if TIBS effectively improves memory function and induces neural plasticity. Participants will: 1. Undergo initial screening including neuropsychological assessments and blood p-tau217 testing to identify preclinical AD. 2. Receive either active personalized TIBS or sham stimulation daily for 40 minutes, 6 days a week, for 2 weeks. 3. Have individualized TIBS parameters (e.g., target localization, intensity) determined using baseline structural MRI and DTI. 4. Undergo real-time high-density EEG monitoring during daily stimulation sessions to enable closed-loop adjustment of stimulation parameters. 5. Participate in follow-up assessments at the end of the 2-week intervention, and at 4 weeks and 12 weeks post-intervention. 6. Receive multimodal imaging (sMRI, rs-fMRI, task-fMRI, DTI) and blood biomarker assessments at various time points. 7. Receive Aβ-PET and tau-PET scans, along with comprehensive neuropsychological assessments, at the 12-week follow-up. 8. Have their safety continuously monitored throughout the study.
CONDITIONS
Official Title
Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals recruited from neurology memory clinics or communities
- Age between 60 and 80 years old, inclusive
- Right-handed
- Cognitive function within normal range for age, gender, and education, or mild cognitive impairment not meeting MCI criteria, or subjective cognitive decline only
- Classified as preclinical Alzheimer's Disease based on 2024 diagnostic criteria with positive plasma p-tau217 or positive amyloid beta PET
- Fully understand the study, voluntarily participate, and provide written informed consent approved by the Ethics Committee
You will not qualify if you...
- Past or present neurological diseases such as stroke, epilepsy, Parkinson's disease, or multiple sclerosis
- Psychiatric disorders including severe depression or severe anxiety
- Systemic diseases causing cognitive decline, including severe thyroid dysfunction, severe liver or kidney disease, or severe nutritional deficiencies
- Taking medications affecting cognitive function (e.g., anticholinergics, benzodiazepines, antipsychotics) that cannot be stopped or adjusted
- Other causes of cognitive decline not related to Alzheimer's Disease
- Contraindications for MRI such as claustrophobia, implanted metallic devices like pacemakers or cochlear implants, or history of head injury with metal fragments retained
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hainan university
Sanya, Hainan, China
Actively Recruiting
2
Xuanwu Hospital of Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Y
Ying Han, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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