Not yet recruitingNAINTERVENTIONAL

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)

This research is looking into a new way to treat depression called Electrical Vestibular Nerve Stimulation (VeNS). This involves wearing a device that sends gentle electrical pulses to a nerve near your ear. The study wants to find out if this device really helps people with major depressive disorder feel better, compared to a dummy (sham) device that doesn't deliver actual stimulation. If you're an adult in the UK between 18 and 80 years old, diagnosed with depression, and already taking a stable antidepressant, you might be able to take part. Participants will be asked to use the device daily and complete questionnaires from home.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Neurovalens Ltd.

Enrolment target

170

Start

01 Apr 2025

Estimated completion

01 Apr 2027

Major Depressive Disorder \(MDD Depressive Disorder, Major

What is this study about?

This study, called the Modius Mood Study, is investigating a new approach to managing major depressive disorder (often just called depression) using something called Electrical Vestibular Nerve Stimulation (VeNS). Imagine a small device that you wear, which delivers very gentle electrical signals to a nerve in your ear. The researchers want to know if this electrical stimulation can help reduce symptoms of depression.

To find this out, they are comparing the active device with a 'sham' (dummy) device. Half the people taking part will receive the active device, and the other half will receive a sham device that looks the same but doesn't actually stimulate the nerve. Neither you nor the study team will know which device you have, which helps make the results fair and accurate. The main goal is to see if the real VeNS device is more effective than the sham device in improving your mood.

This kind of research is important because it could lead to new, non-drug treatments for depression. Major depressive disorder is a serious illness, and finding different ways to help people manage it is a key focus for medical research. By taking part, you’d be contributing valuable information that could help many others in the future.

Key takeaways

Tests a new device (VeNS) for major depression.
Compares an active device to a dummy device.
Participants continue their regular depression medication.
Requires daily 30-minute device use and online check-ins.
Aims to find new non-drug treatment options for depression.
You won't know if you have the active or dummy device.

Who may be eligible?

This study is looking for adults in the UK aged between 18 and 80 years old who have been diagnosed with depression. You need to have a confirmed diagnosis of depression and your depression symptoms should be at a certain level based on a questionnaire.

It's important that you're currently taking an antidepressant medication called an SSRI or SNRI, and you should only be on one of these types of medication. You need to have been on this medication for at least a year (but no more than five years) and your dose must have been stable for at least three months before the study starts. You'll also need to commit to keeping your medication and other depression treatments stable throughout the study.

There are also some practical requirements: you must be able to speak and read English, and have access to Wi-Fi and a computer, laptop, tablet, or smartphone for online appointments and questionnaires. You should be willing to use the device for 30 minutes every day and avoid major lifestyle changes or starting new complementary therapies that could affect your mood during the study.

Quick self-check

Are you between 18 and 80 years old?
Do you have a diagnosis of depression?
Are you currently taking one type of SSRI/SNRI antidepressant, and have been for at least a year?
Has your antidepressant dose been stable for at least 3 months?
Do you have reliable internet access and a smart device (phone/tablet/computer)?
Are you willing to use a device daily for 30 minutes and complete online forms?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first be asked to sign a consent form, which means you understand what the study involves and agree to participate. You'll then go through some health checks and questionnaires to make sure you're suitable for the study. If you meet the criteria, you'll be assigned by chance to either receive the active VeNS device or a sham (dummy) device. Neither you nor the study team will know which one you have.

For the duration of the trial, you will be expected to use the device for 30 minutes every day. You'll also need to complete online questionnaires about your mood and have remote appointments with the study team using a video calling platform. It's crucial that you continue taking your current antidepressant medication at a stable dose throughout the study, and avoid making any major changes to your lifestyle or starting new complementary therapies that might affect your mood. The study duration is not specified but involves daily device usage and regular check-ins.

Potential risks and benefits

Taking part in this study could potentially offer some benefits if the active VeNS device helps improve your depression symptoms. However, since some participants will receive a dummy device, there is no guarantee that you will experience any direct benefit. There might be some mild side effects from using the device, but the study organisers will give you full information about these. You should know that you are free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

VA San Diego Healthcare System
San Diego, United States
Biomedical Science Research University of Ulster, Coleraine
Belfast, United Kingdom

Common questions

What is VeNS?

VeNS stands for Electrical Vestibular Nerve Stimulation. It's a method that uses gentle electrical pulses to a nerve near your ear, which researchers hope might help with depression.

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

No, neither you nor the study team will know if you have the active device or a dummy (sham) device. This is to ensure the results are fair.

Do I need to stop my current medication if I join?

No, you must continue taking your antidepressant medication at a stable dose throughout the entire study. This study is testing if the device adds to your current treatment.

How much time will this take?

You'll need to use the device for 30 minutes each day. You'll also complete online questionnaires and have remote video calls with the study team.

What if I feel worse during the study?

You should always discuss any concerns about your well-being with the study team or your regular doctor. You are free to stop participating in the study at any time.

How to find out more

Joe Reel

trials@neurovalens.com 02890991835 Official trial record

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