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New treatment option for Psychiatric Disorder
Official title Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
ClinicalTrials.gov ID: NCT06433583
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 18
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Thionville, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thionville, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.