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RecruitingNAINTERVENTIONAL

Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

This study is exploring a new, gentle treatment for teenagers who self-harm. The treatment is called transcutaneous auricular vagus nerve stimulation, or taVNS, and it involves very mild electrical stimulation to a specific part of the ear. This stimulation is thought to help the body's natural systems that control stress and pain. Self-harm among young people has become more common, and there's a need for new and accessible ways to help. This particular study isn't looking at whether taVNS stops self-harm directly just yet, but its main goal is to find out if teenagers with self-harm find this treatment easy to use, acceptable, and if they are likely to continue using it at home.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Régional Metz-Thionville
Enrolment target
22
Start
28 Nov 2024
Estimated completion
28 May 2027

What is this study about?

This study is exploring a way to help teenagers who intentionally hurt themselves, a behaviour known as non-suicidal self-injury (NSSI). This can be a very challenging issue, and unfortunately, it's been on the rise, especially after the COVID-19 pandemic. Finding enough help from mental health professionals can be difficult, and current medications don't always have strong evidence for helping with NSSI.

This research is looking at a gentle, non-invasive treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. It involves placing a small device on the ear that sends very mild electrical signals to a nerve called the vagus nerve. This nerve plays a big role in how our body manages stress, pain, and emotions. The idea is that stimulating this nerve might help rebalance some of the body's natural systems that can become out of whack in people who self-harm. For example, some people who self-harm have lower levels of a stress hormone called cortisol, and this stimulation might help the body produce more of it.

The main purpose of this study, however, is not to prove that taVNS stops self-harm. Instead, it's a 'pilot study', which means it's an initial, smaller step. The study wants to find out if this treatment, which can be done at home, is something that teenagers with NSSI find acceptable and whether they are likely to use it regularly. If young people find it easy to use and stick with the treatment, it could pave the way for larger studies in the future to see if it truly helps reduce self-harm.

Key takeaways

  • The study explores a gentle ear stimulation (taVNS) for teenagers who self-harm.
  • It aims to see if teenagers find the treatment acceptable and easy to use at home.
  • The treatment involves mild electrical signals to a nerve that helps manage stress.
  • This is a pilot study, an early step, not a study to directly treat self-harm yet.
  • Participation requires parental/guardian consent for those aged 13-17.
  • There are specific health conditions that would prevent participation.

Who may be eligible?

To be able to join this study, you need to be a teenager aged between 13 and 17 years old who has experienced non-suicidal self-injury (NSSI) as described by health professionals. You also need to be covered by a social security scheme, and your parents or guardians must agree to your participation by signing a consent form. It's important that you can understand the instructions for using the neurostimulation device.

There are certain reasons why you might not be able to join. These include having certain skin conditions on your ear, or some serious health conditions like epilepsy, a heart condition, or a history of blood clots. You also can't take part if you have a pacemaker, another active medical implant, or if you are pregnant or breastfeeding. The staff will also check if you have severe mental health problems like psychosis, severe confusion, or significant developmental disorders. If you are allergic to silicone, or have a cochlear implant on the ear where the stimulation would be, you would also not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 13 and 17 years old?
  2. Have you been diagnosed with non-suicidal self-injury (NSSI) by a healthcare professional?
  3. Do your parents or guardians agree for you to take part and will they sign consent forms?
  4. Do you feel you can understand instructions for using a medical device?
  5. Are you free from certain serious health conditions like epilepsy or a heart problem?
  6. Are you definitely not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

This portion of the clinical trial information is not provided in the original text.

Potential risks and benefits

As this is a pilot study, the main benefit is to help researchers understand if this new treatment method is acceptable and easy for teenagers to use at home, which could lead to better treatment options in the future. There are no direct medical benefits promised from this particular study. Possible risks associated with the stimulation are generally mild and might include skin irritation from the electrode; however, the study staff will carefully assess if you have any conditions that might make the treatment unsafe for you. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Centre Médico-Psychologique adolescents - CHR Metz-Thionville
    Verified postcode
    Thionville, France· Recruiting

Common questions

What is NSSI?

NSSI stands for Non-Suicidal Self-Injury, which means intentionally hurting oneself without the intention to end one's life. It's often a way to cope with difficult emotions.

What is taVNS?

taVNS (transcutaneous auricular vagus nerve stimulation) is a gentle treatment that uses a small device on the ear to send mild electrical signals to a nerve involved in stress and emotions.

Is this a new treatment?

The use of taVNS has been studied for about ten years in other areas, but its use and acceptability in teenagers with NSSI is a newer area of research.

Will this study cure my self-harm?

This pilot study's main goal is to find out if the treatment is acceptable and easy for teenagers to use, not to directly treat or cure self-harm at this stage. It's a step towards future research.

How long does the study last?

The provided information does not specify the exact duration of the study or how long each participant would be involved.

How to find out more

Justine GRIGORCEA, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Pilot Study on the Acceptability of Auricular Vagus Nerve Ne…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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