RecruitingNAINTERVENTIONAL

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI

This study is exploring a new way to help people with spinal cord injuries who are also struggling with depression and inflammation. It's looking at a gentle electrical stimulation applied to the ear, called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS). This treatment aims to stimulate a key nerve, the vagus nerve, which helps control inflammation and mood. Researchers want to see if taVNS can improve depression symptoms and reduce inflammatory markers in people with spinal cord injuries. It's a non-invasive treatment that has shown promise in other groups, and this study will check if it's safe and effective for this specific patient group.

At a glance

Status

Recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

27 Jan 2025

Estimated completion

30 Aug 2026

Spinal Cord Injury Depression

What is this study about?

When someone has a spinal cord injury, it can often affect an important nerve in the body called the vagus nerve. This nerve plays a big role in controlling inflammation and can also affect our mood. Because of this, it's thought that problems with the vagus nerve might contribute to long-term inflammation and depression in people with spinal cord injuries.

This study is investigating a technique called Transcutaneous Auricular Vagus Nerve Stimulation, or taVNS for short. This involves placing a small electrode (like a soft sticky pad) on the skin of the ear. This pad then delivers a very gentle electrical pulse, which researchers hope will stimulate the vagus nerve. This type of treatment has been looked at in other groups of people and has shown some promise in reducing inflammation and improving depression without serious side effects. However, it hasn't been specifically tested in people with spinal cord injuries.

The main goal of this research is to see if taVNS can help treat inflammation and depression in people who have spinal cord injuries. The researchers will also check to see if the treatment changes how the vagus nerve functions in the body. If this gentle treatment proves safe and effective, it could offer a simple, non-invasive, and cost-effective way to help people with spinal cord injuries manage their long-term inflammation and depression.

Key takeaways

This study explores a gentle electrical ear stimulation (taVNS) for spinal cord injury patients.
It aims to reduce depression and inflammation, which are common after spinal cord injury.
The treatment targets the vagus nerve, which helps control body inflammation and mood.
Participants will be randomly assigned to either the active treatment or a placebo.
The study seeks a non-invasive, low-cost way to improve health for this patient group.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have a spinal cord injury. You also need to be experiencing mild to moderate depression, and if you're taking medication for depression, you should have been on a steady dose.

There are some reasons why you might not be able to join. For example, if you have severe depression or have thoughts of harming yourself, this study might not be suitable. It’s also not for people who get severe blood pressure changes (called autonomic dysreflexia), have heart disease, or have certain implanted electrical devices like pacemakers or cochlear implants. If you have epilepsy, cerebral shunts, or are pregnant or planning to become pregnant, you also can't take part.

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 18 years old or older?
Do you have a spinal cord injury?
Do you have mild to moderate depression?
Are you NOT pregnant or trying to get pregnant?
Do you NOT have a pacemaker or other implanted electrical device?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to one of two groups: either you'll receive the active taVNS treatment, or you'll receive a sham (placebo) treatment that feels similar but doesn't stimulate the vagus nerve. The treatment will be given for 30 days.

Over the course of the study, which will last about two years in total, you'll have appointments where researchers will check your depression symptoms, look at how your vagus nerve is working (by measuring your heart rate changes), and measure substances in your body related to inflammation. These checks will happen at the beginning of the study and again after 30 days of treatment. Researchers will also keep an eye on how well you're doing with the treatment and if there are any side effects.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improving your depression symptoms and reducing inflammation if the taVNS treatment is effective. However, as with any study, there's no guarantee you'll receive the active treatment or experience these benefits, and some participants will receive a placebo. Potential risks are expected to be low, as taVNS has been shown to be safe in other groups. You might experience mild side effects, which will be monitored closely. Please remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Parkwood Institute, St Joseph's Health Care London
Verified postcode
London, Canada· Recruiting

Common questions

What is the vagus nerve?

The vagus nerve is an important nerve that runs from your brain to many parts of your body, including your heart and gut. It helps control important body functions like digestion, heart rate, and even how your body handles inflammation and mood.

What is taVNS?

taVNS stands for Transcutaneous Auricular Vagus Nerve Stimulation. It's a gentle, non-invasive method that uses a small electrical device placed on the skin of your ear to stimulate the vagus nerve.

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

No, you won't know whether you're receiving the active taVNS treatment or a sham (placebo) treatment. This is a common practice in studies to ensure the results are as fair and unbiased as possible.

How long will the treatment last each day?

The recommended daily stimulation for participants is four hours per day, with at least one continuous hour.

What if I feel unwell during the study?

Your safety is very important. You will be closely monitored, and any concerns or adverse events should be reported to the study team immediately. You also have the right to stop participating at any time.

How to find out more

David J Allison, PhD.

david.allison@sjhc.london.on.ca 519 646 6100 Official trial record

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