Ear vagus nerve priming plus gentle alternating brain stimulation for teens with non-suicidal self-injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled outpatient trial that compares combined taVNS priming followed by tACS to tACS alone and sham controls in adolescents with DSM-5 non-suicidal self-injury. Participants receive active or sham 25 Hz, 300 µs taVNS followed by active or sham 10 Hz tACS over the left dorsolateral prefrontal cortex in a state-dependent protocol. The trial enrolls right-handed youth aged 12–18 with at least five documented self-injury episodes and one episode in the past month and excludes those with suicide attempts, epilepsy, significant brain injury, recent interventions, or low cognitive screening scores. Outcomes target changes in attentional bias, impulsivity, dlPFC activation, and self-injury frequency to determine whether priming improves tACS response.

Why it matters

Who can join: the full rules

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

Where it's running

• School of Mental Health and Psychological Sciences
  Hefei, Anhui, China Recruiting

Study contacts

• Principal investigator: Hongyan Zhu — School of Mental Health and Psychological Sciences, Anhui Medical University
• Study coordinator: Hongyan Zhu
• Email: 2445011125@stu.ahmu.edu.cn
• Phone: ＋ 86 18155313002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Temporal interference stimulation for non‑suicidal self‑injury in adolescent depression

  This trial will test whether temporal interference stimulation (TIS) can reduce non‑suicidal self‑injury in adolescents and young adults (ages 12–22) with major depressive disorder compared with a sham treatment.

  Recruiting The Second Hospital of Anhui Medical University · Hefei, Anhui · NCT07554755

• Beta-band brain stimulation to reduce impulsive self-injury in teens

  This trial will try twice-daily beta-frequency transcranial alternating current stimulation versus sham in adolescents with non-suicidal self-injury to see if it reduces self-harm episodes and impulsivity and is safe.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT07152925

• Effect of high-definition brain stimulation on non-suicidal self-injury

  This study is testing if a special type of brain stimulation can help teenagers who hurt themselves without wanting to die feel better and understand their behavior better.

  Recruiting Anhui Medical University · Hefei, Anhui · NCT06127056

• Investigating factors affecting treatment outcomes in Dialectical Behavior Therapy for Borderline Personality Disorder

  This study is trying to find out what factors affect how well Dialectical Behavior Therapy works for people with Borderline Personality Disorder and a history of self-harm.

  Recruiting Region Skane · Lund, Skåne County · NCT06106555

• Understanding self-harm behavior in at-risk adolescents

  This study is trying to understand the risks of self-harm in at-risk teens who have been hospitalized for suicide risk, to help create better treatment guidelines.

  Recruiting University of Ljubljana, Faculty of Medicine · Ljubljana and 1 other locations · NCT05765864

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.