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Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Sponsor: Shanghai Mental Health Center
Summary
This study aims to evaluate the clinical effectiveness of triple-daily 15 mA tACS stimulation in adolescents with Nonsuicidal Self-Injury (NSSI) by comparing the outcomes of active versus sham tACS interventions. Participants will be randomly assigned to either the active or sham tACS group. The trial includes a seven-day intervention phase, during which participants receive treatment three times daily, followed by a four-week observation period. The primary hypothesis is that triple-daily 15 mA tACS will significantly reduce both the severity and frequency of self-injurious behaviors compared with sham stimulation. The study's overall goal is to provide evidence for an effective intervention to help adolescents manage and reduce NSSI behaviors.
Official title: Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial
Key Details
Gender
All
Age Range
12 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-05-01
Completion Date
2027-09-30
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Sham-tACS (Nexalin Technology, Inc., Houston, TX, USA)
Participants assigned to the sham-tACS group use a device identical in appearance, weight, size, color, and odor to the active device. The device delivers no effective stimulation but mimics the procedure and duration of the active-tACS sessions (triple-daily sessions). Sessions are administered by trained personnel following the same schedule as the active-tACS group. Participants remain blinded to their group assignment throughout the study.
Active-tACS (Nexalin Technology, Inc., Houston, TX, USA)
Participants are comfortably seated or reclined in a lounge chair and instructed to remain relaxed with minimal interaction during the session. Alternating current stimulation is delivered at 77.5 Hz (±10%) with a current intensity gradually increasing from 1 mA to 15 mA in 2 mA increments. Each increment lasts 300 seconds, with variable intervals between intensity steps (1-3 mA: 5 s; 3-5 mA: 5 s; 5-7 mA: 5 s; 7-9 mA: 5 s; 9-11 mA: 6 s; 11-13 mA: 7 s; 13-15 mA: 10 s). Electrodes are placed on the forehead (4.45 × 9.53 cm, Fpz, Fp1, Fp2) and bilaterally over the mastoids (3.18 × 3.81 cm), following the international 10/20 system. The total stimulation duration at 15 mA is 40 minutes. Stimulation is imperceptible, and the device operates silently. All sessions are administered by trained study personnel following standardized protocols.
Locations (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China