BCI With 40Hz Stimulation in Alzheimer's Disease
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
1 other identifier
interventional
90
1 country
2
Brief Summary
This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 25, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
June 3, 2026
June 1, 2026
1.5 years
May 25, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Montreal Cognitive Assessment - Basic (MoCA-B) Score
The primary outcome is the change in MoCA-B score from baseline to 6 months. The MoCA-B is a validated cognitive screening tool for assessing global cognitive function. The score ranges from 0 to 30, with higher scores indicating better cognitive function. The change score (ΔMoCA-B) will be calculated as the 6-month score minus the baseline score. Assessments will be performed by trained neuropsychologists who are blinded to group assignment.
Baseline (pre-treatment) and 6 months (end of treatment)
Secondary Outcomes (10)
Change in Auditory Verbal Learning Test (AVLT) Score
Baseline, 3 months, and 6 months
Change in Shape Trails Test (STT-A and STT-B) Score
Baseline, 3 months, and 6 months
Change in Digit Span Test (DST) Score
Baseline, 3 months, and 6 months
Change in Structural MRI Parameters
Baseline and 6 months
Change in Functional MRI (fMRI) Parameters
Baseline and 6 months
- +5 more secondary outcomes
Study Arms (3)
40Hz Stimulation Group
EXPERIMENTALFixed 40Hz combined audio-visual stimulation, 60 minutes per day, once daily, for 6 consecutive months.
Individualized Stimulation Group
EXPERIMENTAL40Hz combined audio-visual stimulation with EEG-based closed-loop feedback adjustment, 60 minutes per day, once daily, for 6 consecutive months.
Sham Stimulation Group
SHAM COMPARATORIdentical appearance and operation as the active device, but without effective individualized audio-visual stimulation. Only low-intensity, randomized flashes and audio cues are delivered.
Interventions
Participants receive fixed 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. The stimulation parameters are fixed and do not adjust based on EEG feedback.
Participants receive sham stimulation using a device identical in appearance and weight to the active device. The sham device does not output effective individualized audio-visual stimulation; only low-intensity, randomized flashes and audio cues are delivered.
Participants receive 40Hz combined audio-visual stimulation (visual + auditory) for 60 minutes per day, once daily, for 6 consecutive months. In addition, the device performs EEG acquisition and closed-loop feedback adjustment based on preset algorithms. This allows individualized, closed-loop neuromodulation.
Eligibility Criteria
You may qualify if:
- Diagnosis of Alzheimer's disease according to the NIA-AA 2018 diagnostic criteria.
- Age between 50 and 80 years, inclusive.
- Positive Aβ-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 may not qualify if:
- 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 but not limited to: dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, or mixed dementia; other neurodegenerative diseases (Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, etc.); history of severe brain infection (meningitis/encephalitis) or multiple concussions; metabolic/systemic diseases causing cognitive impairment (syphilis, vitamin B12 or folate deficiency, etc.).
- 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-Aβ antibody immunotherapies.
- Current use of memantine within 30 days prior to intervention.
- Life expectancy \< 24 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (2)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000025, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 2000025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, Chief of Neurology
Study Record Dates
First Submitted
May 25, 2026
First Posted
June 1, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
June 3, 2026
Record last verified: 2026-06