💬In plain words
What the trial is, and whether it could suit you
This study aims to evaluate the clinical effectiveness of triple-daily 15 mA tACS stimulation in adolescents with Nonsuicidal Self-Injury (NSSI) by comparing the outcomes of active versus sham tACS interventions. Participants will be randomly assigned to either the active or sham tACS group. The trial includes a seven-day intervention phase, during which participants receive treatment three times daily, followed by a four-week observation period.
The primary hypothesis is that triple-daily 15 mA tACS will significantly reduce both the severity and frequency of self-injurious behaviors compared with sham stimulation. The study's overall goal is to provide evidence for an effective intervention to help adolescents manage and reduce NSSI behaviors.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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