RecruitingNot Applicable

Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

China66 participantsStarted 2025-05-01

Plain-language summary

In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.

Who can participate

Age range12 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in total NSSI incidents during the 4-week follow-up period post-intervention

Timeframe: 6 weeks

Change in mean NSSI severity levels during the 4-week follow-up period post-intervention

Timeframe: 6 weeks

Trial details

NCT IDNCT06919432

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

TianHong Zhang, Doctor

13127577024 zhang_tianhong@126.com