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Personalized Brain Stimulation for Cognitive Impairment in Older Adults

NCT07208734 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Alzheimer s Disease

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-06-01
Completion
2027-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07208734 on ClinicalTrials.gov