NCT04088643

4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease

The Efficacy of 4Hz Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease: A Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	transcranial alternating current stimulation	The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).
DEVICE	sham stimulation	Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.

Timeline

• Start date: 2019-10-14
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2019-09-13
• Last updated: 2022-07-13

Locations

1 site across 1 country: China