## Protocol Section
### Identification Module
**NCT ID:** NCT06433583

**Acronym:** NEUROMUTE

**Brief Title:** Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

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

#### Organization Study ID Info
**ID:** 2023-01-CHRMT
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Régional Metz-Thionville
### Status Module
#### Completion Date
**Date:** 2026-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Régional Metz-Thionville

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Psychiatric Disorder

**Keywords:**

- non-suicidal self-injury

- transcutaneous auricular vagal nerve stimulation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 22

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: transcutaneous auricular vagal nerve stimulation

**Label:** transcutaneous auricular vagal nerve stimulation (taVNS) treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- transcutaneous auricular vagal nerve stimulation (taVNS) treatment

**Description:** 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.

**Name:** transcutaneous auricular vagal nerve stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Patient adherence to treatment

**Time Frame:** 10 weeks after inclusion

#### Secondary Outcomes

**Description:** 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.

**Measure:** Other caracteristics for patient adherence to treatment

**Time Frame:** 10 weeks after inclusion

**Description:** Assessed by the patient on a Likert scale in a logbook.

**Measure:** Frequency of weekly non-suicidal self-injury (NSSI)

**Time Frame:** weekly, from 2 weeks before treatment and up to 20 weeks after treatment

**Description:** 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.

**Measure:** Anxiety and depression levels

**Time Frame:** at week 0, 2, 10 and 22 after inclusion

**Description:** assessed through patient logbook and consultations with psychiatrist during taVNS treatment

**Measure:** Adverse events

**Time Frame:** up to 22 weeks after inclusion

**Description:** Semi-structured questionnaire at the end of taVNS.

**Measure:** Patient's experience of taVNS

**Time Frame:** at week 10 after inclusion

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 18 Years

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** justine.grigorcea@chr-metz-thionville.fr

**Name:** Justine GRIGORCEA, MD

**Phone:** 00333 82 88 15 03

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Thionville

**Contacts:**

***Contact 1:***

- **Email:** projet-recherche-clinique@chr-metz-thionville.fr

- **Name:** Arpiné EL NAR, PhD

- **Phone:** 0033387557766

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dorin SINDILA, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Centre Médico-Psychologique adolescents - CHR Metz-Thionville

#### Overall Officials

**Official 1:**

**Affiliation:** CHR Metz Thionville

**Name:** Dorin SINDILA, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: HIGH

- As Found: Psychiatric Disorders

- ID: M85

- Name: Problem Behavior

- Relevance: HIGH

- As Found: Psychiatric Disorders

- ID: M19089

- Name: Self-Injurious Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001523

- Term: Mental Disorders

- ID: D000066553

- Term: Problem Behavior

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
