Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

Launched by CENTRE HOSPITALIER RÉGIONAL METZ-THIONVILLE · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method called auricular vagus nerve neurostimulation (taVNS) for adolescents who engage in non-suicidal self-injury (NSSI). NSSI is when someone intentionally harms themselves without wanting to end their life, and it has become more common among young people, especially during the COVID-19 pandemic. The study aims to see if young people aged 13 to 17 with NSSI will stick to using this non-invasive treatment at home, which could help their bodies manage stress and pain better.

To participate in the trial, adolescents must be between 13 and 17 years old and diagnosed with NSSI as outlined in the DSM-5, a manual used by mental health professionals. They also need to have parental or guardian consent and be able to follow instructions for using the device. However, certain health conditions, like having a pacemaker or specific skin issues, may prevent someone from joining. If eligible, participants can expect guidance on using the neurostimulation device and will help researchers understand if this treatment can be effective and accepted by adolescents.

Gender

ALL

Eligibility 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