Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Mental Health Center | OTHER |
| Shandong Mental Health Center | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator |
| |
| Treatment group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sham transcranial Alternating Current Stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | The primary endpoint is defined as the decreased scores of Hamilton Depression Scale-17 (HDRS-17) at the 4-week follow-up compared to baseline scores. HDRS ranges from 0 to 68, with higher scores indicating more severe depression symptoms. The two-sample t-test is used to test the difference in score changes between the treatment group and control group at the 4-week follow-up visit point. | 4 weeks after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The adverse events will be reported by physicians at the 8-week follow-up visit, which items include the number of the events, the severe levels of each event, and its duration time. | 8 weeks, when the study is completed |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunhao Wu | Contact | 008602115021638398 | wuyh_2022@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine | Not yet recruiting | Shanghai | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41904320 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 4, 2026 | |
| Reset | Jan 20, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 4, 2026 | Jan 20, 2026 |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| active tACS | Device | 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. |
|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
|