Personalized temporal interference brain stimulation to improve memory in preclinical Alzheimer's
Effects and Mechanisms of Temporal Interference Brain Stimulation on Memory Function in Preclinical Alzheimer's Disease
NA · Xuanwu Hospital, Beijing · NCT07031687
This project will test whether personalized, imaging-guided temporal interference brain stimulation can improve memory in people aged 60–80 with preclinical Alzheimer's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing (other) |
| Locations | 2 sites (Sanya, Hainan and 1 other locations) |
| Trial ID | NCT07031687 on ClinicalTrials.gov |
What this trial studies
Researchers will deliver personalized, EEG-based closed-loop temporal interference brain stimulation (TIBS) or a sham procedure over a two-week intervention guided by multimodal imaging. Participants are biomarker-defined preclinical AD (positive plasma p-tau217 or positive Aβ PET), right-handed, and will undergo baseline, end-of-intervention, and 4- and 12-week follow-up assessments. Outcomes include hippocampal–cortical functional connectivity measured by fMRI, EEG power spectra, and tests of episodic and working memory, plus safety monitoring. The trial compares active TIBS against sham to determine short- and medium-term effects on cognition and brain network activity.
Who should consider this trial
Good fit: Ideal candidates are right‑handed adults aged 60–80 with biomarker evidence of preclinical Alzheimer's (positive plasma p‑tau217 or positive Aβ PET) who are cognitively normal or have only subjective cognitive decline and can give informed consent.
Not a fit: People with past or current neurological disorders (e.g., stroke, epilepsy, Parkinson's), severe psychiatric or systemic illnesses, those who do not meet biomarker criteria for preclinical AD, or who cannot attend site visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could improve memory performance and strengthen hippocampal‑cortical networks in people with preclinical Alzheimer's disease.
How similar studies have performed: Noninvasive stimulation methods such as TMS and tDCS have shown mixed cognitive results, while temporal interference stimulation is a newer, less-tested approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Aβ 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.
Where this trial is running
Sanya, Hainan and 1 other locations
- Hainan university — Sanya, Hainan, China (RECRUITING)
- Xuanwu Hospital of Capital Medical University — Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Ying Han, PhD — Xuanwu Hospital of Capital Medical University
- Study coordinator: Ying Han, PhD
- Email: hanying@xwh.ccmu.edu.cn
- Phone: +86 13621011941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease