CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
transcranial alternating current stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03920826
NCT03920826N/ACompleted
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The Effects of TRanscranial AlterNating Current Stimulation FOR Patients With Mild Alzheimer's Disease (TRANSFORM-AD Study): A Randomized Controlled Clinical Trial

Xuanwu Hospital, Beijing·interventional·Posted Apr 19, 2019·Updated Oct 18, 2022

In Brief

A clinical study evaluating transcranial alternating current stimulation and sham stimulation for Alzheimer Disease. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The goal of this study is to explore the efficacy and safety of transcranial alternating current stimulation (tACS) in patients with mild Alzheimer's disease (AD). The study will recruit 40 individuals with mild AD with evidence of amyloid plaques in the brain through Positron Emission Tomography (PET) imaging. Participants will undergo baseline cognitive assessment, structural and functional MRI characterization, PiB-PET, and resting-state EEG measurement. The participants will be randomized to either a tACS group or a sham stimulation group. At the end of the intervention and 3-month follow-up, all subjects will repeat the baseline assessments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 19, 2019
Enrollment StartSep 11, 2019
Primary CompletionJan 15, 2022
Study CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.2 years ago

Interventions

transcranial alternating current stimulationdevice

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 gamma-frequency (40 Hz) and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).

sham stimulationdevice

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.