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Clinical Treatment of Depression with Transcutaneous Electrical Cranial-Auricular Acupoints Stimulation Efficacy and mechanism research

Optimization and Application of an Intelligent Precision Antidepressant Based on Transcutaneous Electrical Cranial-Auricular Acupoints Stimulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001758
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-17
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

4/20Hz group:4/20 Hz TECAS stimulation
20/100Hz Group:20/100 Hz TECAS stimulation
sham group:sham TECAS stimulation

Sponsors

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Age 18–65 years, no gender restrictions, right-handed; 2) HAMD-17 score 8 = score = 24; 3) No risk of suicide, all responses on the C-SSRS (Seriousness of Suicide Rating Scale) are "no," and the score for item 3 (suicide) on the HAMD-17 is <3 points; 4)Resided in the Beijing area prior to and after enrollment; 5)Able to complete an 8-week treatment period and a 32-week follow-up period; 6)Voluntarily participating in this study and having signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Individuals with a history of other mental disorders diagnosed according to DSM-5 criteria, such as bipolar disorder, schizophrenia, substance use disorders, personality disorders, or intellectual disabilities; 2) Individuals with severe or unstable cardiovascular, respiratory, hepatic, renal, hematological, or other systemic diseases; 3) Individuals with alcohol (or drug) dependence or abuse; 4) Pregnant or breastfeeding women, or those planning to become pregnant; 5) Individuals with outer ear defects, ulcers, or skin allergies; 6) Individuals who have participated in any other clinical study within the past 3 months; 7) Individuals with contraindications for MRI (those with implanted metal devices or claustrophobia).

Design outcomes

Primary

MeasureTime frame
17-Hamilton Depression Scale;—

Secondary

MeasureTime frame
Fatigue Severity Scale;EuroQol Five Dimensions Questionnaire-3Level;Pittsburgh Sleep Quality Index;Negative Cognitive Processing Bias Questionnaire;Perceived Deficits Questionnaire – Depression;Subject self-efficacy evaluation;Brian Magnetic Resonance Imaging;Electroencephalogram;Electrocardiogram;—

Countries

China

Contacts

Public ContactYanan Zhao

Institute of Acupuncture and Moxibustion China Academy of Chinese Medical Sciences

2578868775@qq.com18800107425

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026