BCI With 40Hz Stimulation in Alzheimer's Disease
Recruiting · NCT07618481 · Interventional (participants receive a specific treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine - Shanghai, Shanghai Municipality, China