Personalized Brain Stimulation for Cognitive Impairment in Older Adults

NCT07208734 | Enrolling By Invitation

• 1 other identifier: 2025116
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).

  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.

Study Arms (2)

Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training

EXPERIMENTAL

Device: Transcranial Alternating Current Stimulation (tACS); Other: AI-based Cognitive Training

Sham intervention

SHAM COMPARATOR

Other: Sham intervention

Interventions

Transcranial Alternating Current Stimulation (tACS) DEVICE

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)

Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training

AI-based Cognitive Training OTHER

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.

Transcranial Alternating Current Stimulation (tACS) or AI-based Cognitive Training

Sham intervention OTHER

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.

Sham intervention

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatients or outpatients aged 50-90 years;
• 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;
• Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1;
• Able to communicate fluently in Chinese (non-illiterate);
• 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;
• Provision of written informed consent.

You may not qualify if:

• Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging;
• Moderate to severe white matter lesions (Fazekas score 3-6);
• Presence of any cause of consciousness disorder;
• Severe aphasia or motor disability that prevents completion of neuropsychological assessments;
• Current psychiatric disorders;
• History of alcohol dependence, drug addiction, traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus, or other neurological disorders that may cause cognitive impairment;
• Systemic diseases that may contribute to mild cognitive impairment (e.g., hepatic or renal insufficiency, endocrine disorders, vitamin deficiencies);
• Considered unsuitable for participation by the investigators.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University, Beijing, Beijing 100053

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

CN (1)