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

NCT ID: NCT07152925

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-05-31

Brief Summary

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.

Conditions

Depression Disorders; Non-suicidal Self-injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Active stimulation: deliver 20 minutes of beta-band tACS intervention.

Group Type: ACTIVE_COMPARATOR

Beta-frequency transcranial alternating current stimulation

Intervention Type: DEVICE

Active beta-frequency transcranial alternating current stimulation: 20 Hz tACS delivered through a 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak, 100 % intensity, gradually ramped up over 30 s, maintained for 20 min, then ramped down over 30 s; two sessions per day with at least 4 h between sessions, repeated for 7 consecutive days (14 total sessions).

Control group

Sham stimulation will be administered with identical treatment parameters, duration, and number of sessions as the active intervention. For the control group, the current will be ramped up to 2 mA and then ramped down to 0 mA within the first 30 seconds.

Group Type: SHAM_COMPARATOR

sham beta-frequency transcranial alternating current stimulation

Intervention Type: DEVICE

Sham transcranial alternating current stimulation: identical 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak current ramped up over 30 s and immediately ramped down to 0 mA, followed by 19.5 min of no stimulation to match the 20-min session duration of active tACS; delivered twice daily (≥4 h apart) for 7 consecutive days (14 total sessions).

Interventions

Beta-frequency transcranial alternating current stimulation

Active beta-frequency transcranial alternating current stimulation: 20 Hz tACS delivered through a 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak, 100 % intensity, gradually ramped up over 30 s, maintained for 20 min, then ramped down over 30 s; two sessions per day with at least 4 h between sessions, repeated for 7 consecutive days (14 total sessions).

Intervention Type: DEVICE

sham beta-frequency transcranial alternating current stimulation

Sham transcranial alternating current stimulation: identical 4×1-ring high-definition electrode montage centered on left DLPFC (F3), 2 mA peak-to-peak current ramped up over 30 s and immediately ramped down to 0 mA, followed by 19.5 min of no stimulation to match the 20-min session duration of active tACS; delivered twice daily (≥4 h apart) for 7 consecutive days (14 total sessions).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wang Meiling

student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lei Zhang, doctor

Role: STUDY_DIRECTOR

School of Mental Health and Psychological Sciences, Anhui Medical University

Locations

School of Mental Health and Psychological Sciences, Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meiling Wang, bachelor

Role: CONTACT

1605280093@qq.com

+86 136 4707 0027

Facility Contacts

Lei Zhang, doctor

Role: primary

anyipsychology@163.com

+86 138 6612 9450

Other Identifiers

AHMU-beta-band-tACS-NSSI

Identifier Type: -

Identifier Source: org_study_id