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The Efficacy of 4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease: A Randomized Controlled Clinical Trial
The goal of this study is to explore the efficacy and safety of 4Hz transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD, and the participants will be randomized to either a 4 Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions across 3 weeks (21 days). At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.
Background: Recently, transcranial alternating current stimulation (tACS), which could interact with ongoing neuronal activity, has emerged as a potentially effective and promising treatment for Alzheimer's disease (AD), and the 4Hz frequency was suggested to improve working memory Methods: The proposed study is a double-blinded, randomized controlled trial that will include 40 individuals with mild AD, and the participants will be randomized to either a 4Hz tACS group or a sham stimulation group. Both groups will undergo 30 one-hour sessions in 3 weeks (21 days). The outcome measures will be assessed at baseline, end of intervention and 3 months after the first session. Primary outcome is global cognitive function, assessed by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), and the second outcomes include changes in other neuropsychological assessments, structural MRI, resting electroencephalogram (EEG) and simultaneous EEG-functional MRI (fMRI).
Age
45 - 75 years
Sex
ALL
Healthy Volunteers
No
Xuanwu Hospital, Capital Medical University
Beijing, China
Start Date
October 14, 2019
Primary Completion Date
October 1, 2023
Completion Date
December 1, 2023
Last Updated
July 13, 2022
40
ESTIMATED participants
transcranial alternating current stimulation
DEVICE
sham stimulation
DEVICE
Lead Sponsor
Xuanwu Hospital, Beijing
NCT07178210
NCT04123314
Data Source & Attribution
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