NCT07031687

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

Recruiting now NA Last updated 15 August 2025

What this trial tests

NA trial testing Active TIBS in Alzheimer Disease in 1,200 participants. Currently enrolling.

Timeline

1 July 2025

Primary endpoint
31 December 2028

31 December 2029

Quick facts

Lead sponsor	Xuanwu Hospital, Beijing
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,200
Start date	1 July 2025
Primary completion	31 December 2028
Estimated completion	31 December 2029
Sites	2 locations across China

Drugs / interventions tested

• Active TIBS
• Sham TIBS

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Xuanwu Hospital, Beijing

Who can join

Adults 60 to 80, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.