Status:
RECRUITING
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Self-Injurious Behavior
Eligibility:
All Genders
12-21 years
Phase:
NA
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-Inj...
Detailed Description
Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06919432
Start Date
May 1 2025
End Date
September 30 2027
Last Update
June 12 2025
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030