Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial
Shanghai Mental Health Center
66 participants
May 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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.
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Interventions
Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.
The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06919432