An interventional study of transcutaneous auricular vagal nerve stimulation in Psychiatric Disorder, sponsored by Centre Hospitalier Régional Metz-Thionville. Recruiting at 2 sites in France. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Other
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 22 is below the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 10 weeks after inclusion
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.
Time frame: 10 weeks after inclusion
Frequency of weekly non-suicidal self-injury (NSSI)
Assessed by the patient on a Likert scale in a logbook.
Time frame: 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.
Time frame: at week 0, 2, 10 and 22 after inclusion
Adverse events
assessed through patient logbook and consultations with psychiatrist during taVNS treatment
Time frame: up to 22 weeks after inclusion
Patient's experience of taVNS
Semi-structured questionnaire at the end of taVNS.
Time frame: at week 10 after inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2028, 48 months after the start.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 48 months is above that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion May 2027 → Nov 2028 and completion May 2027 → Nov 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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