NCT07208734

Personalized Brain Stimulation for Cognitive Impairment in Older Adults

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to improve the treatment and care of older adults with cognitive impairment through three related projects. Project 1: Development of a personalized cognitive training program. Using advanced computer algorithms, we will match training tasks to each patient's needs across multiple cognitive domains. About 300 participants will be enrolled from hospitals and community health centers in two provinces to test the effectiveness of this program in a randomized controlled trial. Project 2: Development of a personalized brain stimulation program. Based on brain imaging data and artificial intelligence models, we will create individualized transcranial alternating current stimulation (tACS) plans to deliver precise, safe, and effective stimulation. About 160 participants will be recruited from the same sites to evaluate safety and effectiveness in a randomized controlled trial. Project 3: Development of a data governance and ethics framework. Building on the first two projects, we will review international literature and consult experts in ethics, geriatrics, neuroscience, and data governance to create a framework for managing multimodal data and ethical issues in cognitive impairment research. Together, these projects aim to provide personalized, scientifically validated treatment strategies and ensure that research data are managed safely and ethically.

Conditions

• Alzheimer s Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-06-01
• Completion: 2027-11-30
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: China