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Development and Multicenter Validation of a Personalized Transcranial Alternating Current Stimulation Protocol for Cognitive Impairment in Older Adults
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.
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.
Age
50 - 90 years
Sex
ALL
Healthy Volunteers
No
Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053
Beijing, Beijing Municipality, China
Start Date
May 1, 2024
Primary Completion Date
June 1, 2027
Completion Date
November 30, 2027
Last Updated
October 6, 2025
460
ESTIMATED participants
Transcranial Alternating Current Stimulation (tACS)
DEVICE
AI-based Cognitive Training
OTHER
Sham intervention
OTHER
Lead Sponsor
Xuanwu Hospital, Beijing
NCT07262645
NCT07279103
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07332260