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ENROLLING BY INVITATION
NCT07208734
NA

Personalized Brain Stimulation for Cognitive Impairment in Older Adults

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

This study aims to develop and test new personalized treatments for older adults with cognitive impairment. Project 1: Create a personalized cognitive training program using computer algorithms to match training tasks to individual needs. About 300 participants will join a randomized trial at hospitals and community health centers. Project 2: Develop a personalized brain stimulation program (tACS) based on brain imaging and artificial intelligence. About 160 participants will be enrolled to test safety and effectiveness. Project 3: Build a framework for ethical data management by reviewing international practices and consulting experts. Together, these projects will provide evidence for safe, effective, and personalized care, while ensuring responsible use of research data.

Official title: Development and Multicenter Validation of a Personalized Transcranial Alternating Current Stimulation Protocol for Cognitive Impairment in Older Adults

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2024-05-01

Completion Date

2027-11-30

Last Updated

2025-10-06

Healthy Volunteers

No

Interventions

DEVICE

Transcranial Alternating Current Stimulation (tACS)

Gamma TranscraniaThis intervention uses a personalized transcranial alternating current stimulation (tACS) protocol specifically designed for older adults with cognitive impairment. Unlike standard brain stimulation approaches, this protocol is individualized through artificial intelligence-based modeling of each participant's brain imaging data to optimize electric field distribution. The study will evaluate both safety and effectiveness in a multicenter randomized controlled trial.l Alternating Current Stimulation (tACS)

OTHER

AI-based Cognitive Training

This intervention provides a personalized cognitive training program tailored to multiple cognitive domains. Using algorithm-based task matching, the system delivers training exercises adapted to each participant's cognitive profile. The program is designed to target memory, attention, executive function, and language, and will be validated through a multicenter randomized controlled trial.

OTHER

Sham intervention

The sham stimulation group will undergo the same setup procedures as the active tACS group, including electrode placement and device operation. However, no effective current will be delivered beyond an initial brief sensation, ensuring participants cannot distinguish sham from active stimulation. This allows blinding of participants and investigators to treatment allocation.

Locations (1)

Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053

Beijing, Beijing Municipality, China