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

NCT06433583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-12-05

No results posted yet for this study

Summary

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.

Conditions

  • Psychiatric Disorder

Interventions

DEVICE

transcutaneous auricular vagal nerve stimulation

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.

Sponsors & Collaborators

  • Centre Hospitalier Régional Metz-Thionville

    lead OTHER

Principal Investigators

  • Dorin SINDILA, MD · CHR Metz Thionville

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2027-05-28
Completion
2027-05-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06433583 on ClinicalTrials.gov