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Effects of taVNS Combined With tACS on Adolescents With Non-Suicidal Self-Injury

RecruitingNAAges 12 Years - 22 YearsAllAnhui Medical University
NCT07486804 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

NSSI behavior is highly prevalent among adolescents, and its mechanisms are closely associated with attentional bias toward self-injury-related information and impulsivity, both of which may be related to reduced dlPFC activation levels. Introducing taVNS as a priming stimulus to pre-regulate brain state and optimize subsequent tACS treatment response provides a novel approach to addressing inconsistent intervention effects. Simultaneously, this facilitates a shift in the brain from passive stimulus reception to active state regulation, offering important theoretical foundations for developing more precise and efficient cross-modal neuromodulation therapies.This study aims to systematically validate the efficacy of a combined protocol using taVNS as a priming modality followed by tACS over the left dlPFC through a randomized controlled trial (RCT). The investigators hypothesize that: โ‘ 

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ5 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) * Aged 12-18 years * Right-handed * Possess formal education experience sufficient to comprehend experimental protocols * Normal or corrected-to-normal binocular visual acuity * Voluntarily participate with legal guardians providing written informed consent Exclusion Criteria: * Montreal Cognitive Assessment (MoCA) score \< 26 * History of suicide attempts * History of epilepsy, brain surgery, tumors, or clinically significant head trauma * History of substance abuse or severe physical diseases * Received physical or psychological interventions within the past three months
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What it tests

  • 25Hzใ€300us transcutaneous auricular vagus nerve stimulation and10hz transcranial alternating current stimulation
  • sham 25Hzใ€300us transcutaneous auricular vagus nerve stimulation and 10hz transcranial alternating current stimulation
  • active 25Hzใ€300us transcutaneous auricular vagus nerve stimulation and sham10hz transcranial alternating current stimulation
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Where

1 site
School of Mental Health and Psychological Sciences
Hefei, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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