Psychiatric DisorderNEUROMUTENCT06433583
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
A study testing transcutaneous auricular vagal nerve stimulation in people with Psychiatric Disorder, run by Centre Hospitalier Régional Metz-Thionville at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- transcutaneous auricular vagal nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Nov 2024to 28 Nov 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
Etablissement Publique de Santé Mentale (EPSM) Metz-Jury
Metz, Grand Est, 57245
Olivier SCARPA, Principal Investigator, +33 03 87 18 44 22, olivier.scarpa@epsm-metz-jury.fr
- Recruiting
Centre Médico-Psychologique adolescents - CHR Metz-Thionville
Thionville
Andreia CARVALHO DE FERIATS, 0033387553323, projet-recherche-clinique@chr-metz-thionville.fr
Dorin SINDILA, MD
About this study
Official title: Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents
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.
Read more
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
- Being tested
- transcutaneous auricular vagal nerve stimulation
- Keywords
- non-suicidal self-injury, transcutaneous auricular vagal nerve stimulation
- Medical subject headings
- Mental Disorders, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagal nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous auricular vagal nerve stimulation (taVNS) treatment | Experimental | Not described Receives: Device: transcutaneous auricular vagal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks after inclusion
Secondary outcomes (5)
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.
Measured: 10 weeks after inclusion
Frequency of weekly non-suicidal self-injury (NSSI)
Assessed by the patient on a Likert scale in a logbook.
Measured: weekly, from 2 weeks before treatment and up to 20 weeks after treatment
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.
Measured: at week 0, 2, 10 and 22 after inclusion
Adverse events
assessed through patient logbook and consultations with psychiatrist during taVNS treatment
Measured: up to 22 weeks after inclusion
Patient's experience of taVNS
Semi-structured questionnaire at the end of taVNS.
Measured: at week 10 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start28 Nov 2024
- Primary completion28 Nov 2028 (estimated)
- Study completion28 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorin SINDILA, MD, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433583
- Sponsor's protocol ID
- 2023-01-CHRMT
- Acronym
- NEUROMUTE
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No