Using auricular nerve stimulation to help adolescents with self-injury
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents
This study is testing if a new type of nerve stimulation can help teenagers who hurt themselves feel better and find it acceptable as a treatment option.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville Academic / other |
| Locations | 1 site (Thionville) |
| Trial ID | NCT06433583 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the acceptability of transcutaneous auricular vagus nerve stimulation (taVNS) in adolescents aged 13 to 17 who engage in non-suicidal self-injury (NSSI). The study aims to explore how this neurostimulation technique can influence the autonomic nervous system and potentially alleviate symptoms associated with NSSI. Given the rising prevalence of NSSI among adolescents, especially during the COVID-19 pandemic, this approach seeks to provide an alternative to traditional psychiatric interventions, which are often limited in availability and efficacy. Participants will receive taVNS treatment while their responses and experiences will be monitored to assess the intervention's acceptability.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13 to 17 who have been diagnosed with non-suicidal self-injury disorder.
Not a fit: Patients with contraindications to taVNS, such as certain cardiac conditions or active implantable devices, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel, non-invasive treatment option for adolescents struggling with self-injury behaviors.
How similar studies have performed: While taVNS has been studied for various conditions, this specific application in adolescents with NSSI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adolescents aged between 13 and 17 years old * Patients with NSSI disorder as defined by DSM-5 * Patient affiliated to a social security scheme * Patient who parents or guardians have signed a free and informed consent form * Patient able to understand neurostimulation instructions Exclusion Criteria: * Contraindication to taVNS: * Malformation, skin pathology of the external ear. (piercings in the area concerned must be removed during the neurostimulation session). * Children with sleep apnea syndrome treated with NIV (non-invasive ventilation) * Presence of epileptic seizures * Proven cardiac pathology on the advice of the attending cardiologist * History of venous or arterial thrombosis * Adolescent with pacemaker or defibrillator * Adolescent with an active implantable device * Pregnancy (based on anamnestic criteria, checked by blood test if necessary) * Patients with psychotic episodes, confusional states or severe neurodevelopmental disorders * Patients with an allergic skin reaction to silicone (component of the ear electrode) * Patients with a cochlear implant on the stimulation side * Pregnant or breast-feeding women * Minor under guardianship * Minor under judicial measure or sanction
Where this trial is running
Thionville
- Centre Médico-Psychologique adolescents - CHR Metz-Thionville — Thionville, France (Recruiting)
Study contacts
- Principal investigator: Dorin SINDILA, MD — CHR Metz Thionville
- Study coordinator: Justine GRIGORCEA, MD
- Email: justine.grigorcea@chr-metz-thionville.fr
- Phone: 00333 82 88 15 03
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.