NCT07152925RECRUITINGNA

The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury

This clinical trial aims to determine whether beta-band transcranial alternating current stimulation (tACS) can improve impulse inhibition in adolescents with non-suicidal self-injury (NSSI) and to evaluate its safety. The primary questions it seeks to answer are: * Can beta-band tACS significantly reduce the frequency of self-injury and scores on impulsivity scales in adolescents with NSSI? * What discomfort or medical issues may participants experience during tACS intervention? Researchers will compare beta-band tACS with sham stimulation (a procedure that mimics the real stimulation without delivering effective current) to verify its efficacy. Participants will: * Receive two sessions of either tACS or sham stimulation daily, spaced 4 hours apart, for 7 consecutive days (14 sessions in total). * Undergo scale assessments, behavioral tasks, and eye-tracking tests before and after the intervention. * Record any self-injury episodes and adverse reactions, with continuous monitoring and psychological support provided by a professional team.

Sponsor

Anhui Medical University

Enrollment

60 participants

Sites

1 locations

Start Date

March 2025

Completion

May 2026

Depression DisordersNon-suicidal Self-injuryBeta-frequency transcranial alternating current stimulationsham beta-frequency transcranial alternating current stimulation

View on ClinicalTrials.gov

Primary Outcomes

Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

The ANSAQ is a brief, self-report tool specifically designed for adolescents aged 12-18 to quantify non-suicidal self-injury (NSSI) over the past year. It is used both to screen for clinically relevant self-harm and to track changes in self-injury frequency after an intervention.

UPPS-P Impulsive Behavior Scale (UPPS-P)

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

The UPPS-P is a 59-item self-report questionnaire that measures five distinct facets of impulsivity: Negative Urgency, (lack of) Premeditation, (lack of) Perseverance, Sensation Seeking, and Positive Urgency. Each item is rated on a 4-point Likert scale from 1 (agree strongly) to 4 (disagree strongly); items are reverse-scored so that higher scores indicate greater impulsivity.

Brief Barratt Impulsiveness Scale (BBIS)

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

The BBIS is an 8-item, self-report subset of the well-known Barratt Impulsiveness Scale. Each item (e.g., "I act on the spur of the moment") is answered on a 4-point scale: 1 = rarely/never, 2 = occasionally, 3 = often, 4 = almost always/always. Total scores range 8-32; higher scores indicate greater impulsivity.

Eye movement index-fixation time

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Fetching protocol from ClinicalTrials.gov…

NCT07152925RECRUITINGNA

The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury

Sponsor

Anhui Medical University

Enrollment

60 participants

Sites

1 locations

Start Date

March 2025

Completion

May 2026

Depression DisordersNon-suicidal Self-injuryBeta-frequency transcranial alternating current stimulationsham beta-frequency transcranial alternating current stimulation

View on ClinicalTrials.gov

Primary Outcomes

Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

UPPS-P Impulsive Behavior Scale (UPPS-P)

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

Brief Barratt Impulsiveness Scale (BBIS)

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

Eye movement index-fixation time

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Balloon Analog Risk Task-Total number of Balloon explosions

Once at baseline (pre-treatment) and once at the end of treatment on Day 8.

In the computer-based Balloon Analog Risk Task (BART), participants are shown 30 virtual balloons one at a time. They press "F" to inflate (pump) each balloon; every pump increases potential earnings by ¥0.5 but also raises the risk of explosion. Explosion points are random (1-128 pumps, mean 64). Participants can press "J" at any time to stop inflating and bank the current reward. "Total number of balloon explosions" is the count of balloons that burst across all 30 trials. Higher numbers reflect greater risk-taking and poorer impulse control. The score is obtained at baseline (Day 0) and after the 7-day intervention (Day 8); a ≥ 20 % reduction in explosions from baseline is considered a clinically relevant improvement in inhibitory control.

Eligibility

Min Age

12 Years

Max Age

22 Years

Sex

all

Healthy Volunteers

View full criteria

Inclusion Criteria:

* 1\) Meet the proposed diagnostic criteria for non-suicidal self-injury (NSSI) in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with ≥5 documented self-injury episodes and at least one incident within the past month as assessed by the Adolescent Non-Suicidal Self-Injury Assessment Questionnaire (ANSAQ); 2) Aged 12-18 years; 3) Right-handed; 4) Possess formal education experience sufficient to comprehend experimental protocols; 5) Normal or corrected-to-normal binocular visual acuity; 6) Voluntarily participate with legal guardians providing written informed consent.

Exclusion Criteria:

* 1\) Montreal Cognitive Assessment (MoCA) score \< 26; 2) History of suicide attempt(s); 3) Medical history of epilepsy, brain surgery, intracranial tumors, metal implants in the skull, or clinically significant head trauma; 4) History of substance use disorder, brain injury, severe somatic diseases, psychiatric disorders, or comorbid DSM-5 psychiatric conditions; 5) Prior receipt of transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or repetitive transcranial magnetic stimulation (rTMS) within the past 3 months

The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

The Impact of Beta-band Transcranial Alternating Current Stimulation (tACS) on Impulse Inhibition in Adolescents With Non-suicidal Self-injury

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)