Actively Recruiting
EEG-Based Non-Invasive Brain-Computer Interface Combined With 40Hz Audio-Visual Stimulation for Cognitive Function in Patients With Alzheimer's Disease: A Randomized Double-Blind Controlled Study
Led by Ruijin Hospital · Updated on 2026-06-03
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a non-invasive brain-computer interface (BCI) combined with 40Hz audio-visual stimulation to study its effects on cognitive function in patients with Alzheimer's disease (AD). This randomized, double-blind, sham-controlled trial includes 90 participants diagnosed with AD confirmed by Ab2-PET scans according to NIA-AA criteria. The study aims to assess both safety and effectiveness of this neuromodulation technique. Participants are randomly assigned to one of three groups: a fixed 40Hz stimulation group receiving daily 60-minute audio-visual stimulation for six months, an individualized stimulation group receiving similar stimulation adjusted in real-time via EEG feedback, and a sham stimulation group receiving inactive stimulation with low-intensity randomized flashes and sounds for the same duration. The trial compares the effects of fixed versus closed-loop stimulation and a control condition. Participants will undergo cognitive assessments including the Montreal Cognitive Assessment-Basic (MoCA-B) at baseline and after six months to measure changes in cognition. Additional tests, brain imaging (MRI, fMRI, Ab2-PET, tau-PET), EEG monitoring, and blood biomarker analysis will be performed at baseline and follow-ups. Safety and tolerability are monitored throughout the six-month treatment period. The study duration and procedures offer detailed evaluation of cognitive outcomes and brain function in treated individuals.
CONDITIONS
Brief Title
BCI With 40Hz Stimulation in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
- Age between 50 and 80 years, inclusive.
- Positive Ab2-PET scan result.
- Has a stable caregiver who can assist with daily stimulation intervention.
- Chronic medical conditions stable for at least 30 days.
- Adequate vision and hearing to perform testing (at minimum, ability to perceive light and communicate in daily conversation).
- Good mobility (able to walk independently or with assistive devices).
- Willing and able to provide voluntary signed informed consent.
You will not qualify if you...
- History of epilepsy or seizure disorder.
- Inability to undergo MRI or presence of significant abnormalities on MRI screening.
- Geriatric Depression Scale (GDS) score > 6.
- Current suicidal ideation or suicide attempt within the past 6 months.
- Other major neurological disorders, including dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, mixed dementia, Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, history of severe brain infection, or multiple concussions.
- Metabolic or systemic diseases causing cognitive impairment such as syphilis or vitamin B12 or folate deficiency.
- Psychiatric disorders.
- Severe cardiac disease, chronic liver/kidney/respiratory disease, or uncontrolled diabetes mellitus or thyroid disease.
- History of drug or alcohol abuse within the past 12 months.
- Current exposure to anti-Ab2 antibody immunotherapies.
- Current use of memantine within 30 days prior to intervention.
- Life expectancy less than 24 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 consecutive months
Participants receive daily 60-minute sessions of audio-visual stimulation using a device. Depending on the group, stimulation is fixed 40Hz, individualized with EEG feedback, or sham stimulation without effective audio-visual output.
Daily sessions for 6 months with periodic assessments at baseline, 3 months, and 6 months
Trial Site Locations
Total: 2 locations
1
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000025
Actively Recruiting
2
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 2000025
Actively Recruiting
Research Team
C
Chao Gao
B
Binyin Li, MD，Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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