Triple-daily 15 mA tACS for adolescent nonsuicidal self-injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adolescents with recurrent nonsuicidal self-injury are randomized to receive either active or sham tACS targeting the forehead and both mastoids. The intervention features an intensive phase of triple-daily 15 mA sessions totaling 40 sessions over two weeks, followed by weekly follow-up observations for four weeks. EEG and ECG are recorded at baseline, after the first session, at the end of the intensive phase, and at a six-week follow-up to track physiological and clinical changes. All evaluations are performed under standardized conditions to compare clinical recovery between active and sham groups.

Why it matters

Who can join: the full rules

Inclusion Criteria：

* Diagnosis of Non-Suicidal Self-Injury (NSSI) according to the DSM-5 Section III diagnostic criteria, including:

Criterion A: At least five or more NSSI episodes in the past year.

Criterion B: NSSI is expected to relieve interpersonal difficulties, negative thoughts or emotions, or induce a positive emotional state.

Criterion C: Prior to NSSI, the individual experiences one or more of the following: interpersonal problems, negative thoughts or emotions, distress that is difficult to control, or frequent preoccupation with NSSI.

Criterion D: NSSI is socially unacceptable or limited to minor self-injury.

Criterion E: NSSI causes clinically significant distress or impairment in social, academic, or other important areas of functioning.

Criterion F: NSSI is not better explained by psychotic disorder, delirium, substance use/withdrawal, or another medical or mental disorder.

* At least one NSSI episode in the past month.
* Age 12 to 21 years.
* Informed consent obtained from participants; for those under 18, consent must also be obtained from parents or legal guardians.

Exclusion Criteria：

* Current or past organic brain disorders or neurological disorders.
* High or imminent risk of suicide, as assessed by clinicians during routine screening.
* Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.
* Presence of cochlear implants, cardiac pacemakers, implanted medical devices, or metal in the brain.
* Previous or current use of psychoactive or psychotropic substances.
* Pregnancy or lactation.
* Participation in another ongoing clinical trial.
* Refusal to provide informed consent to participate.
* Other circumstances deemed unsuitable for participation by the investigators.

Where it's running

• Shanghai Mental Health Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: TianHong Zhang, Doctor — Shanghai Mental Health Center
• Study coordinator: TianHong Zhang, Doctor
• Email: zhang_tianhong@126.com
• Phone: 13127577024

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ear vagus nerve priming plus gentle alternating brain stimulation for teens with non-suicidal self-injury

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.