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Personalized Brain Stimulation for Cognitive Impairment in Older Adults
Sponsor: Xuanwu Hospital, Beijing
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
Conditions
Interventions
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)
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.
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