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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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 (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals.

The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out.

Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • transcutaneous auricular vagal nerve stimulation

Treatment groups

22 Participants
are divided into 1 treatment group