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

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.

Study Overview

• Status: Recruiting
• Conditions: Self-Injurious Behavior
• Intervention / Treatment: Device: Active-tACS; Device: Sham-tACS

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 targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: TianHong Zhang, Doctor; Phone Number: 13127577024; Email: zhang_tianhong@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: TianHong Zhang, Doctor; Phone Number: 13127577024; Email: zhang_tianhong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the active-tACS group; This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days.	Device: 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 Comparator: the sham-tACS group; Participants in the sham-tACS group will undergo the same protocol, utilizing a sham tACS incapable of delivering active stimulation. They will be kept unaware of their assigned treatment.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total NSSI incidents during the 4-week follow-up period post-intervention	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.	6 weeks
Change in mean NSSI severity levels during the 4-week follow-up period post-intervention	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.	6 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: TianHong Zhang, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: non-invasive brain stimulation; Transcranial Alternating Current Stimulation (tACS)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior
• Other Study ID Numbers: 2024y1023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No