Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07618481
NA

BCI With 40Hz Stimulation in Alzheimer's Disease

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-05-01

Completion Date

2027-10-31

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DEVICE

40Hz Stimulation Group

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.

DEVICE

Individualized Stimulation Group

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.

DEVICE

Sham Stimulation Group

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.

Locations (2)

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