Pilot Study Assessing Home Use of Ear Vagus Nerve Stimulation to Prevent Self-Injury in Adolescents

What this Trial Is About

Researchers are exploring the use of transcutaneous auricular vagus nerve stimulation taVNS to help adolescents with non-suicidal self-injury NSSI disorder, a behavior involving intentional self-harm without suicidal intent. NSSI is common among adolescents and has increased during the COVID-19 pandemic. This study aims to understand if taVNS, which stimulates the vagus nerve and may influence stress hormone production, can improve the regulation of the stress response and reduce self-injury frequency in this population. Participants will use a device called TENS ECO PLUS with a vagus nerve ear electrode for taVNS treatment at home. The treatment involves daily stimulation sessions of 10 minutes twice a day or 20 minutes once a day for 8 consecutive weeks. The study includes an initial inclusion at week 0, treatment from week 2 to week 10, and follow-up until week 22. The main focus is to assess how well adolescents stick to this treatment schedule. Throughout the study, participants will be monitored for adherence to the treatment, frequency of self-injury episodes, anxiety and depression levels, and any adverse effects. Their experiences with taVNS will be collected at week 10. Follow-up assessments will continue up to 22 weeks after inclusion to evaluate long-term effects and safety. The study aims to provide insight into the feasibility of this home-based neurostimulation for adolescents with NSSI.

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