RecruitingNAINTERVENTIONAL

Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in Depression

This study is investigating a different way to treat depression and bipolar disorder called transcutaneous auricular vagus nerve stimulation (tVNS). Unlike older treatments that involved surgery, tVNS is a non-surgical method. While tVNS has shown promise, it's still considered experimental because we don't fully understand how it works or the best ways to use it. This study aims to fill those gaps. They will recruit 86 patients who will either receive tVNS or a 'sham' (dummy) version for six weeks, alongside their usual care. Researchers will collect various details about the participants to understand if tVNS helps and how it affects their body and mind. The goal is to discover new ways to measure progress and predict who might benefit most from this treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Max-Planck-Institute of Psychiatry

Enrolment target

Start

18 Mar 2025

Estimated completion

17 Mar 2030

Depressive Disorder Bipolar Disorder

What is this study about?

Depression is a very common condition that can have a big impact on people's lives. While there are existing treatments, some people don't respond well to them, or the treatments have side effects. One treatment, called vagus nerve stimulation (VNS), involves a small surgery to place a device in the body. Because of this surgery, VNS isn't suitable for everyone.

Researchers are now looking into a newer, gentler approach called transcutaneous auricular vagus nerve stimulation, or tVNS. This method doesn't involve surgery; instead, it uses a small device placed on the ear to send mild electrical pulses. While tVNS has shown some potential in helping people with depression, we don't yet fully understand how it works in the body or the best ways to give the treatment. This means it's still considered an experimental treatment.

This study, called "AddVNS," aims to find out more. Around 86 patients will take part, and they will receive either tVNS or a 'sham' (dummy) treatment for six weeks, in addition to their regular care. By studying many different aspects of their health, including body measurements, brain activity, blood samples, and how they feel, the researchers hope to learn how tVNS affects the body and mind, which could help identify who might benefit most from this non-surgical approach in the future.

Key takeaways

This study explores a non-surgical treatment for depression and bipolar disorder.
It's called transcutaneous auricular vagus nerve stimulation (tVNS), applied to the ear.
The study aims to understand how tVNS works and identify who might benefit most.
Participants will receive either real tVNS or a dummy treatment for six weeks.
Taking part involves daily sessions and various health assessments.
Your regular medical care will continue alongside the study treatment.

Who may be eligible?

To be able to join this study, you need to be an adult between 18 and 65 years old and be capable of giving your full permission to take part. You also need to have a diagnosis of depression or bipolar disorder with current depressive symptoms, as determined by a doctor. Women who can become pregnant must be using effective contraception throughout the study.

There are certain reasons why you might not be able to join. These include being under 18 or over 65, being pregnant or breastfeeding, or having certain serious medical conditions like severe heart problems, significant brain diseases, or acute drug or alcohol issues. You also can't take part if you have certain metal implants in your body or if you are already receiving other types of brain stimulation treatments like ECT or rTMS. If a medical condition of your ear makes tVNS impossible, you also wouldn't 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.

Are you between 18 and 65 years old?
Have you been diagnosed with depression (including bipolar depression)?
Are you able to provide consent for yourself?
If you are a woman of childbearing age, are you using effective contraception?
Do you have any metal implants in your body or certain severe health conditions? (These might mean you can't join)
Are you currently receiving other types of brain stimulation treatment? (This might mean you can't join)

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through some checks to make sure you're suitable. Once enrolled, you will continue with your usual medical care for depression. On top of this, you will receive either the actual tVNS treatment or a 'sham' (dummy) tVNS treatment. This will happen three times a day, from Monday to Friday, for a period of six weeks. Each daily session will last between 30 and 60 minutes, depending on how you tolerate it. The researchers will be collecting quite a lot of information about you throughout the study, including details about your mood, thinking skills, and physical health, possibly through questionnaires, brain scans, and blood tests.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving a new, non-surgical treatment that could help with your depression. You would also be contributing valuable information that could help improve future treatments for others. However, like all medical studies, there are potential risks. The tVNS device might cause some discomfort on your ear, and as tVNS is experimental, its long-term effects are not fully known. You might also find the multiple assessments and daily treatment sessions demanding. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Max Planck Institute of Psychiatry
Verified postcode
Munich, Germany· Recruiting

Common questions

What is tVNS?

tVNS is a gentle, non-surgical treatment that uses small electrical pulses on the ear to try and help with depression.

Is tVNS a recognised treatment for depression?

No, it's currently considered an experimental treatment. This study aims to learn more about how it works and whether it's effective.

Will I know if I'm getting the real treatment or the dummy one?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting the real tVNS and who is getting the sham treatment until after the study ends.

How long will I be in the study?

The main treatment period is six weeks, during which you'll have daily stimulation sessions. There may be follow-up assessments before and after this period.

What if I feel unwell during the study?

The study team will monitor your health closely, and you can report any concerns or side effects to them immediately. You can also withdraw from the study at any point.

How to find out more

Evangelos Kokolakis, MD

ambulanz@psych.mpg.de 0049-89-30622-1000 Official trial record

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