NCT07486804 Effects of taVNS Combined With tACS on Adolescents With Non-Suicidal Self-Injury
| NCT ID | NCT07486804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Medical University |
| Condition | Non-suicidal Self-injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-10-16 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: ① Compared to tACS intervention alone, this combined approach will not only demonstrate non-inferiority in overall therapeutic efficacy but, more importantly, significantly reduce inter-individual variability in treatment response to tACS. This would mitigate the issue of high clinical response heterogeneity and enhance the stability and predictability of treatment outcomes. ② Early behavioral biomarkers of intervention response are anticipated: Immediate improvements in attentional bias following a single combined intervention session will significantly predict reductions in the frequency and intensity of Non-Suicidal Self-Injury (NSSI) after a full course (14 sessions) of treatment. This suggests that early positive changes in cognitive function could serve as valid indicators predicting long-term clinical efficacy, offering a critical time window for implementing individualized treatment adjustments. ③ The study will elucidate the effects of the taVNS-primed combined tACS treatment on neuroimaging mechanisms in adolescents with NSSI.
Eligibility Criteria
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 ≥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) * 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
Contact & Investigator
Hongyan Zhu
PRINCIPAL INVESTIGATOR
School of Mental Health and Psychological Sciences, Anhui Medical University
Frequently Asked Questions
Who can join the NCT07486804 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 22 Years, studying Non-suicidal Self-injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07486804 currently recruiting?
Yes, NCT07486804 is actively recruiting participants. Contact the research team at 2445011125@stu.ahmu.edu.cn for enrollment information.
Where is the NCT07486804 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07486804 clinical trial?
NCT07486804 is sponsored by Anhui Medical University. The principal investigator is Hongyan Zhu at School of Mental Health and Psychological Sciences, Anhui Medical University. The trial plans to enroll 90 participants.