Ear vagus nerve priming plus gentle alternating brain stimulation for teens with non-suicidal self-injury
Effects of Combined taVNS and tACS on Adolescents With Non-Suicidal Self-Injury: A Randomized Controlled Trial
This study will test whether brief transcutaneous auricular vagus nerve stimulation (taVNS) given before mild 10 Hz transcranial alternating current stimulation (tACS) over the left dlPFC can reduce self-injury-related attention biases, impulsivity, and self-injury behaviors in adolescents aged 12–18 with non-suicidal self-injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 12 Years to 22 Years |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07486804 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are right-handed adolescents aged 12–18 who meet DSM-5 criteria for non-suicidal self-injury with at least five lifetime episodes and one episode in the past month, can understand the procedures, and have no recent physical or psychological interventions.
Not a fit: Patients with a history of suicide attempts, epilepsy, brain surgery or tumors, clinically significant head trauma, substance abuse, severe medical conditions, MoCA < 26, or those who recently received other interventions are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined noninvasive stimulation approach could offer a more precise outpatient treatment to reduce self-injury behaviors and improve attention and impulse regulation in affected adolescents.
How similar studies have performed: Small studies have shown some promise for taVNS and for tACS separately in mood, attention, or cognitive modulation, but using taVNS as a priming step before tACS is a novel, relatively untested combined approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hefei, Anhui
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.