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

RecruitingNAAges 13 Years - 18 YearsAllCentre Hospitalier Régional Metz-Thionville
NCT06433583 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury. Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication. The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion. Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder. Transcutaneous neurostimulation of the atrial vagus nerve

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📋 Eligibility rules (as published)
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
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What it tests

  • transcutaneous auricular vagal nerve stimulation
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Where

2 sites
Etablissement Publique de Santé Mentale (EPSM) Metz-Jury
Metz, France
Centre Médico-Psychologique adolescents - CHR Metz-Thionville
Thionville, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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