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Search / Trial NCT07031687

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

Launched by XUANWU HOSPITAL, BEIJING · Jun 12, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new type of brain stimulation called Temporal Interference Brain Stimulation (TIBS) to see if it can help improve memory in people who are in the very early stages of Alzheimer’s disease, before symptoms become obvious. The study uses a personalized approach, where brain scans and electrical brain activity (EEG) help guide the treatment to target specific brain areas involved in memory. Researchers want to find out if this treatment can strengthen brain connections, improve memory and thinking skills, and remain safe over time.

People aged 60 to 80 who are right-handed and have normal or slightly declined memory—based on tests and blood markers indicating early Alzheimer’s changes—may be eligible. Participants will receive either the real brain stimulation or a sham (inactive) treatment for 40 minutes a day, six days a week, over two weeks. Throughout the study, participants will have brain scans, memory tests, and safety checks at several time points, including up to 12 weeks after treatment. This study hopes to better understand how personalized brain stimulation might support memory and brain health in those at risk for Alzheimer’s disease.

Gender

ALL

Eligibility 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.

About Xuanwu Hospital, Beijing

Xuanwu Hospital, located in Beijing, is a leading clinical research institution renowned for its commitment to advancing medical knowledge and improving patient care. Affiliated with Capital Medical University, the hospital specializes in neurology and rehabilitation, providing a robust framework for innovative clinical trials. With a multidisciplinary team of experienced researchers and healthcare professionals, Xuanwu Hospital focuses on conducting high-quality, ethically sound studies that aim to explore new treatment modalities and enhance therapeutic outcomes. Through its dedication to research excellence and patient-centered approaches, Xuanwu Hospital plays a pivotal role in the advancement of healthcare solutions both locally and globally.

Locations

Beijing, , China

Sanya, Hainan, China

Patients applied

0 patients applied

Trial Officials

Ying Han, PhD

Principal Investigator

Xuanwu Hospital of Capital Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported