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 range

12 Years – 21 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Self-Injurious Behavior trials