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

NCT06433583 | Recruiting

• 1 other identifier: 2023-01-CHRMT
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

non-suicidal self-injury; transcutaneous auricular vagal nerve stimulation

Outcome Measures

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.

  10 weeks after inclusion

Secondary Outcomes (5)

• Other caracteristics for patient adherence to treatment

  10 weeks after inclusion

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

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

• Anxiety and depression levels

  at week 0, 2, 10 and 22 after inclusion

• Adverse events

  up to 22 weeks after inclusion

• Patient's experience of taVNS

  at week 10 after inclusion

Study Arms (1)

transcutaneous auricular vagal nerve stimulation (taVNS) treatment

EXPERIMENTAL

Device: transcutaneous auricular vagal nerve stimulation

Interventions

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.

transcutaneous auricular vagal nerve stimulation (taVNS) treatment

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

Centre Médico-Psychologique adolescents - CHR Metz-Thionville

Thionville, France

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Dorin SINDILA, MD

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine GRIGORCEA, MD

CONTACT

00333 82 88 15 03; justine.grigorcea@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 29, 2024
• Study Start: November 28, 2024
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)