Actively Recruiting

Phase Not Applicable
Age: 12Years - 22Years
All Genders
NCT07486804

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

Led by Anhui Medical University · Updated on 2026-03-23

90

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria for non-suicidal self-injury with at least 5 episodes and one in the past month
  • Aged 12 to 18 years
  • Right-handed
  • Have enough formal education to understand study procedures
  • Normal or corrected vision in both eyes
  • Voluntarily agree to participate with legal guardian consent
Not Eligible

You will not qualify if you...

  • Montreal Cognitive Assessment score below 26
  • History of suicide attempts
  • History of epilepsy, brain surgery, brain tumors, or significant head injury
  • History of substance abuse or serious physical illness
  • Received physical or psychological treatment in the last three months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

School of Mental Health and Psychological Sciences

Hefei, Anhui, China

Actively Recruiting

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Research Team

H

Hongyan Zhu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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