Actively Recruiting
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
Led by Centre Hospitalier Régional Metz-Thionville · Updated on 2024-12-05
22
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 whose parents or guardians have signed a free and informed consent form
- Patient able to understand neurostimulation instructions
You will not qualify if you...
- Contraindications to taVNS, including malformation or skin pathology of the external ear (piercings must be removed during stimulation)
- Children with sleep apnea syndrome treated with non-invasive ventilation
- Presence of epileptic seizures
- Proven cardiac pathology based on cardiologist advice
- History of venous or arterial thrombosis
- Adolescents with pacemaker, defibrillator, or active implantable device
- Pregnancy or breastfeeding (confirmed if needed by blood test)
- Patients with psychotic episodes, confusional states, or severe neurodevelopmental disorders
- Allergic skin reaction to silicone (ear electrode component)
- Patients with cochlear implant on the stimulation side
- Minor under guardianship
- Minor under judicial measure or sanction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre Médico-Psychologique adolescents - CHR Metz-Thionville
Thionville, France
Actively Recruiting
Research Team
J
Justine GRIGORCEA, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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