NCT06919432 Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
| NCT ID | NCT06919432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Mental Health Center |
| Condition | Self-Injurious Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2025-05-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
TianHong Zhang, Doctor
PRINCIPAL INVESTIGATOR
Shanghai Mental Health Center
Frequently Asked Questions
Who can join the NCT06919432 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Self-Injurious Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919432 currently recruiting?
Yes, NCT06919432 is actively recruiting participants. Contact the research team at zhang_tianhong@126.com for enrollment information.
Where is the NCT06919432 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06919432 clinical trial?
NCT06919432 is sponsored by Shanghai Mental Health Center. The principal investigator is TianHong Zhang, Doctor at Shanghai Mental Health Center. The trial plans to enroll 66 participants.