Efficacy and Safety of tACS for Depression: a Multicenter RCT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sham transcranial Alternating Current Stimulation, active tACS.
- Who it may be relevant to
- Registry conditions: Depression Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Transcranial Alternating Current Stimulation for Depression: a Multicenter Randomized Controlled Trial Study
Overview
Transcranial alternating current stimulation (tACS) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. Randomized controlled trials (RCTs) of depression treated by tACS have been conducted but provided limited and incongruous results. We designed a multi-center RCT to evaluate the efficacy and safety of tACS for depression. Eligible participants will be patients diagnosed with depression (HDRS-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. A total of 72 participants will be recruited from 4 clinic centers. Participants will be randomized 1:1 to active tACS or sham stimulation group. The study staff and the participants are blinded to the randomization results. Stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (DLPFC) using frequency of 10Hz and amplitude of 1.5 to 2.0 mA. The intervention will last for 4 weeks, containing 20 40-minute sessions in total. Another 4-week observation will be followed by the end of the intervention. Participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. Psychological scales are used for the evaluation of their mental and quality of life. Besides, electroencephalogram (EEG) recording and magnetic resonance imaging (MRI) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.
Interventions
- Device sham transcranial Alternating Current Stimulation
we use fade-in, short-stimulation, fade-out (FSF) stimulation pattern, with 60s-long fade-in/out periods, 2.0mA peak current at the beginning and the end of stimulation session - Device active tACS
The active tACS protocol lasted for 40 min of continuous sine-wave stimulation with the frequency of 10Hz and an amplitude ranging from 1.5mA to 2.0mA, adjusted according to the tolerability among individuals.
Primary outcome measures
- Clinical remission [Time frame: 4 weeks after the intervention]
Secondary outcome measures (1)
- Adverse events [Time frame: 8 weeks, when the study is completed]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of depressive disorder;
- Age ranges between 18 and 65 years;
- HDRS-17 score equals to or above 8;
- No medical history/Under stable antidepressant treatment in one month;
Exclusion criteria
- Combination of other psychotic disorders and neurological diseases;
- History of invasive brain surgeries;
- Non-invasive neurostimulation treatments within 3 months;
- Physical condition that may endanger patients' safety during the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine — Shanghai
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Publications
- Wu Y, Ning C, Shi L, Wang J, Ye K, Shen Z, Wang Y, Wang D, Guo H, Qiu X, Pan Y, Paerhati H, Li D, Mo Y, Wan J, Hu H, Cao Y, Sun B, Lv X. A multicenter randomized clinical trial of portable transcranial alternating current stimulation for major depressive disorder. NPJ Digit Med. 2026 Mar 28;9(1):392. doi: 10.1038/s41746-026-02575-9. PMID 41904320
Identifiers
NCT: NCT06891326 · 20240913