Efficacy of Triple-daily 15mA tACS on Adolescent NSSI

NCT06919432 | Recruiting

• 1 other identifier: 2024y1023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Self-Injurious Behavior

Keywords

Transcranial Alternating Current Stimulation (tACS); non-invasive brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

the active-tACS group

EXPERIMENTAL

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

the sham-tACS group

SHAM COMPARATOR

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

Interventions

Active-tACS DEVICE

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 active-tACS group

Sham-tACS DEVICE

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.

the sham-tACS group

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• TianHong Zhang, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TianHong Zhang, Doctor

CONTACT

13127577024; zhang_tianhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both clinical staff and participants were blinded to the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The present clinical protocol is designed as a double-blind, parallel, sham-controlled, randomized clinical trial.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)