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

Psychiatric Disorder Clinical Trial

— NEUROMUTE  

Official title:

Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433583
• Other study ID #: 2023-01-CHRMT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 18, 2024
• Est. completion date: December 18, 2026

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Justine GRIGORCEA, MD
• Phone: 00333 82 88 15 03
• Email: justine.grigorcea[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: December 18, 2026
• Est. primary completion date: June 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Centre Médico-Psychologique adolescents - CHR Metz-Thionville	Thionville

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 weeks after inclusion
Secondary	Frequency of weekly non-suicidal self-injury (NSSI)	Assessed by the patient on a Likert scale in a logbook.	weekly, from 2 weeks before treatment and up to 20 weeks after treatment
Secondary	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.	at week 0, 2, 10 and 22 after inclusion
Secondary	Adverse events	assessed through patient logbook and consultations with psychiatrist during taVNS treatment	up to 22 weeks after inclusion
Secondary	Patient's experience of taVNS	Semi-structured questionnaire at the end of taVNS.	at week 10 after inclusion