Personalized Brain Stimulation for Cognitive Impairment in Older Adults

NCT07208734 · tracked via the Priya Life Science China tracker

Sponsor

Xuanwu Hospital, Beijing

Phase

Not applicable

Started

2024-05-01

Last updated

2025-10-06

Condition(s) studied

Alzheimer s Disease

Investigational drug(s) / intervention(s)

Transcranial Alternating Current Stimulation (tACS)AI-based Cognitive TrainingSham intervention

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.

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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: 1. Inpatients or outpatients aged 50-90 years; 2. Patients diagnosed with amnestic mild cognitive impairment (aMCI) due to AD or mild dementia due to AD, based on the 2018 NIA-AA clinical diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association; 3. Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1; 4. Able to communicate fluently in Chinese (non-illiterate); 5. For those currently receiving cholinesterase inhibitor therapy (e.g., donepezil or rivastigmine), the treatment dose must be stable, defined as a fixed dosage administered continuously for at least six weeks, with no adjustment of the medication regimen during the study period; 6. Provision of written informed consent. Exclusion Criteria: 1. Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging; 2. Moderate to severe white matter lesions (Fazekas score 3-6); 3. Presence of any cause of consciousness disorder; 4. Severe aphasia or motor disability that prevents completion of neuropsychological assessments; 5. Current psychiatric disorders; 6. History of alcohol dependence, drug addiction, traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus, or other neurological disorders that may cause cognitive impairment; 7. Systemic diseases that may contribute to mild cognitive impairment (e.g., hepatic or renal insufficiency, endocrine disorders, vitamin deficiencies); 8. Considered unsuitable for participation by the investigators.

Primary outcome measure(s)

Moca score — Participants will undergo a screening period, a baseline period, an 8-week visit, and a 6-month visit (calculated from the first intervention) during the trial.

Trial sites (1)

Facility	City	Region	Status
Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053	Beijing	Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07208734 on ClinicalTrials.gov ↗ ← All trials in China