Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

Condition(s) studied

Investigational drug(s) / intervention(s)

Active-tACS: 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.

Sham-tACS: 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.

Study 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

Primary outcome measure(s)

• Change in total NSSI incidents during the 4-week follow-up period post-intervention — 6 weeks
  It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The primary outcome is the proportion of participants achieving a ≥50% decrease in NSSI frequency within the past month at Day 42, as measured by the SITBI-R. A threshold of 50% reduction was selected based on its clinical relevance as an indicator of intervention efficacy.
• Change in mean NSSI severity levels during the 4-week follow-up period post-intervention — 6 weeks
  It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The SITBI-R assesses NSSI severity using a 5-point scale (minimum = 1, maximum = 5), where higher scores indicate more severe outcomes: Level 1 (mild NSSI without skin damage) to Level 5 (severe NSSI requiring medical intervention). Comparative analysis of severity-level changes between the active-tACS and sham-tACS groups will be conducted at the 4-week follow-up post-intervention.

Trial sites (1)

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