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

Обзор

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.

Вмешательства

• Устройство 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).
• Устройство 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).

Первичные конечные точки

• Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) reduction in the frequency of self-injury [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• UPPS-P Impulsive Behavior Scale (UPPS-P) [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• Brief Barratt Impulsiveness Scale (BBIS) [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• Eye movement index-fixation time [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• Eye movement index-fixation counts [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• Balloon Analog Risk Task-Total number of Balloon explosions [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]

Вторичные конечные точки (6)

• Hamilton Depression Scale (HAMD-17) score [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• Hamilton Anxiety Scale (HAMA-14) score [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• the score of Moca [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• the score of TAS-20 [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• the score of ERQ [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]
• the score of PANSI [Срок оценки: Once at baseline (pre-treatment) and once at the end of treatment on Day 8.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• School of Mental Health and Psychological Sciences, Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07152925 · AHMU-beta-band-tACS-NSSI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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