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A non-inferiority study of transcranial alternating current stimulation(tACS) versus electroconvulsive therapy(ECT) in adolescent major depressive disorder

A non-inferiority study of transcranial alternating current stimulation(tACS) versus electroconvulsive therapy(ECT) in adolescent major depressive disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097404
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

depression

Interventions

Positive Control Group (ECT Group):The ECT treatment received by patients in this group is the standard treatment method of the Department of Psychiatry at the First Affiliated Hospital of Chongqing M
The Experimental Treatment Group (tACS Group) :The Nexalin ADI device is used, with electrode placement at F1, F2, FZ (frontal regions), and both mastoids. The treatment involves applying an alternati

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 13-17 years old who visit our hospital's outpatient department; 2. MDD diagnosis is made according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and assessed by at least one professional psychiatrist; 3. Meet the criteria of a score of =25 on the Hamilton Depression Rating Scale; 4. Have not previously undergone physical treatments such as electroconvulsive therapy, alternating current, or direct current; 5. Are able to understand the content of the questionnaire and answer truthfully; 6. Voluntarily participate in this project and have a guardian sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with comorbid mental disorders; 2. Patients with relative contraindications to ECT or neuromodulation treatments (such as having severe physical diseases, intracranial hypertension, severe infection and fever, taking reserpine-containing drugs, being allergic to anesthetic muscle relaxants, having other risk factors for general anesthesia, etc.); 3. Patients with substance abuse or dependence; 4. Patients with impaired skin integrity at the electrode placement site; 5. Patients with implanted electronic devices; 6. Patients who are uncooperative and unable to complete assessments/who refuse to complete the 12-week clinical follow-up.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Beck Suicide Intention Scale;Self Rating Depression Symptom Scale;Generalized Anxiety Disorder Scale;Pittsburgh sleep quality index;Perceived Deficits Questionnaire – Depression;International Physical Activity Questionnaires - Short Form;Clinical Global Impressions;functional near- infrared spectroscopy;functional magnetic resonance imaging, fMRI;event-related potential of EEG;

Countries

China

Contacts

Public ContactLi Kuang

The First Affiliated Hospital of Chongqing Medical University

kuangli0308@163.com+86 139 0837 9733

Outcome results

None listed

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