Triple-daily 15 mA tACS for adolescent nonsuicidal self-injury
Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial
The researchers will test whether triple-daily 15 mA transcranial alternating current stimulation (tACS) can reduce nonsuicidal self-injury in adolescents aged 12–21 by comparing active versus sham stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 12 Years to 21 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06919432 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 12–21-year-olds who meet DSM-5 criteria for NSSI with five or more episodes in the past year (and at least one in the past month), who are not taking psychotropic medication and have no prior neurostimulation exposure, and who can provide consent with guardian permission as required.
Not a fit: Patients with elevated or imminent suicidal risk, neurological implants or disorders, pregnancy or lactation, prior neurostimulation exposure, current psychotropic medication use, or inability to attend the intensive in-person sessions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a noninvasive treatment option that reduces the frequency or severity of nonsuicidal self-injury in adolescents.
How similar studies have performed: Use of tACS specifically for adolescent NSSI is novel and largely untested, though related noninvasive brain stimulation approaches (TMS/tDCS) have shown mixed and preliminary results for self-harm–related outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria. * Five or more NSSI episodes in the past year and at least one NSSI episode in the past month. * Age between 12 and 21 years. * Informed consent from parents or legal guardians. * Informed consent from participants aged 15 years and above. Exclusion Criteria: * Current or history of organic brain disorders or neurological disorders. * Elevated or imminent suicidal risk, as assessed by clinicians during routine screening. * Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments. * Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain. * Previous or current use of psychotropic medication. * Pregnancy or lactation. * Participation in another concurrent clinical trial. * Refusal to provide informed consent to participate in the trial. * Other circumstances deemed unsuitable for participation by researchers.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.