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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • transcutaneous auricular vagal nerve stimulation

    Device

    The use of TENS ECO PLUS and the vagus nerve ear electrode medical devices for transcutaneous auricular vagal nerve stimulation (taVNS) everyday for 10 minutes twice a day or 20 minutes for 8 successive weeks. Patients are included at week 0, use taVNS between week 2 and 10, and are followed up until week 22. Patient adherence: percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 cumulative weeks.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: transcutaneous auricular vagal nerve stimulation (taVNS) treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient adherence to treatment

percentage of patients performing 20 minutes of daily stimulation on at least 5 days a week for at least 6 weeks.

Time frame
10 weeks after inclusion

Secondary outcomes

1

Other caracteristics for patient adherence to treatment

Cumulative daily duration of stimulation, number of daily taVNS sessions performed, number of days per week with at least one session, number of weeks with at least one session, number of premature study exists and reasons.

Time frame
10 weeks after inclusion
2

Frequency of weekly non-suicidal self-injury (NSSI)

Assessed by the patient on a Likert scale in a logbook.

Time frame
weekly, from 2 weeks before treatment and up to 20 weeks after treatment
3

Anxiety and depression levels

Using the Hospital Anxiety Depression (HAD) scale The Hospital Anxiety and Depression Scale (HADS) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.

Time frame
at week 0, 2, 10 and 22 after inclusion
4

Adverse events

assessed through patient logbook and consultations with psychiatrist during taVNS treatment

Time frame
up to 22 weeks after inclusion

Other outcomes

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