BCI With 40Hz Stimulation in Alzheimer's Disease
ConditionAlzheimer Dementia (AD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
40Hz Stimulation Group
DeviceParticipants 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.
Individualized Stimulation Group
DeviceParticipants 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.
Sham Stimulation Group
DeviceParticipants 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 40Hz Stimulation GroupExperimental treatment 1 intervention
Group B: Individualized Stimulation GroupExperimental treatment 1 intervention
Group C: Sham Stimulation GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-treatment) and 6 months (end of treatment)Secondary outcomes
1
Change in Auditory Verbal Learning Test (AVLT) Score
The AVLT is a validated neuropsychological test assessing verbal learning and memory function. The test evaluates immediate recall, delayed recall, and recognition. Higher scores indicate better verbal memory performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Time frame
Baseline, 3 months, and 6 months2
Change in Shape Trails Test (STT-A and STT-B) Score
The STT is a validated neuropsychological test assessing executive function, attention, and psychomotor speed. STT-A primarily measures processing speed, while STT-B measures executive function and task-switching ability. Lower completion time indicates better performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Time frame
Baseline, 3 months, and 6 months3
Change in Digit Span Test (DST) Score
The DST is a validated neuropsychological test assessing working memory and attention. The test includes forward digit span (attention) and backward digit span (working memory). Higher scores indicate better working memory performance. Assessments will be performed by trained neuropsychologists blinded to group assignment.
Time frame
Baseline, 3 months, and 6 months4
Change in Structural MRI Parameters
Changes in structural brain imaging parameters will be assessed using 3T MRI, including gray matter volume, cortical thickness, and hippocampal volume. These parameters will be used to evaluate the neuroprotective effects of the intervention. Imaging data will be analyzed by neuroradiologists blinded to group assignment.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov