Using auricular nerve stimulation to help adolescents with 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Médico-Psychologique adolescents - CHR Metz-Thionville
  Thionville, France Recruiting
• Etablissement Publique de Santé Mentale (EPSM) Metz-Jury
  Metz, Grand Est, France Not yet 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

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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.