RecruitingNAINTERVENTIONAL

Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

This study is exploring a new approach to help people who have speaking difficulties, called aphasia, more than six months after a stroke. Aphasia makes it hard to use or understand language. While traditional speech therapy helps, access can be limited. This study combines computer-based speech therapy with a gentle electrical stimulation on the ear, called transcutaneous vagus nerve stimulation (tVNS). tVNS is a safe method already approved for headaches. We want to see if this combination can help improve word-finding and make daily communication easier. The study will also check how safe and easy it is for people to use this treatment at home for six weeks.

At a glance

Status

Recruiting

Phase

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

25 Apr 2024

Estimated completion

01 Jan 2027

Aphasia Chronic Stroke

What is this study about?

This research is looking for ways to help people who have trouble speaking, understanding, reading, or writing after a stroke. This condition is called aphasia, and it affects about a third of all stroke survivors. While speech and language therapy is very helpful, sometimes after the first few months following a stroke, it can be harder to access or might not be as intense as needed. We know that even years after a stroke, people with aphasia can still improve, but these improvements don't always translate into real-life conversations.

This study is investigating a new method called transcutaneous vagus nerve stimulation (tVNS). This involves wearing a small device on the ear that delivers a gentle electrical pulse to a nerve called the vagus nerve. This technique is non-invasive, meaning it doesn't involve surgery, and is already considered safe for conditions like headaches. There's also some promising early evidence that similar stimulation can help with movement recovery after a stroke. We are hoping it might also help with language recovery for people with long-term aphasia.

The main goal of this pilot study is to see if it's safe and easy for people with long-term aphasia after a stroke to use this tVNS device at home, combined with computer-based speech and language therapy. We will also be looking to see if this combination helps people with their word-finding difficulties. Participants will be split into two groups: one will receive the active tVNS, and the other a 'sham' (inactive) device, without knowing which one they have. This will help us carefully assess the effects. This is the first study of its kind for aphasia, and if it looks promising, it could lead to larger studies to confirm how well it works.

Key takeaways

This study explores a new way to help with speaking difficulties (aphasia) after a stroke.
It combines computer speech therapy with a gentle ear stimulation device (tVNS).
We want to see if it improves word-finding and is safe and easy to use at home.
Participation lasts six weeks and involves using the device and therapy at home.
This is a pilot study, meaning it helps decide if a larger study is worthwhile.

Who may be eligible?

This study is looking for adults aged 18 or over who have aphasia (difficulty with language) due to a stroke that happened at least six months ago. You should have problems finding the right words.

You should be able to take part in the computer-based therapy, which includes being able to see well enough to use a computer. If you need some help understanding or completing tasks, that's okay, support can be provided.

However, you cannot take part if you have certain medical conditions like a pacemaker or other implanted electrical devices, damage to your vagus nerve, or specific heart problems. You also can't be currently receiving other speech and language therapy, be pregnant, or be unable to speak English. Severe deafness, even with hearing aids, would also prevent you from joining.

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.

Have you had a stroke more than 6 months ago?
Do you have problems with your speech, specifically finding words?
Can you see well enough to use a computer?
Do you have a pacemaker or other implanted electrical device?
Are you currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved for a total of six weeks. You'll be randomly put into one of two groups: one where you use the active vagus nerve stimulation device, and one where you use a 'sham' (inactive) device. You won't know which group you are in.

During these six weeks, you'll use the stimulation device at home and complete computer-based speech and language therapy exercises. The study team will explain exactly how to use the equipment and what exercises to do. You won't need to attend many in-person visits, as much of the therapy and device use is designed to be done in your own home. There will be initial assessments, and then follow-up checks during and after the six-week period to see how you're doing and if there are any changes in your word-finding abilities. We will also check on your safety and how comfortable you find the treatment.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improving your word-finding skills or communication abilities. However, as this is a pilot study, there's no guarantee of direct personal benefit. The information we gather will be very valuable in helping us understand if this treatment could help others in the future. Possible risks with tVNS are generally mild, such as skin irritation where the device is placed, or mild discomfort. More serious side effects are rare, but the research team will monitor you closely. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sheffield Teaching Hospitals NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is aphasia?

Aphasia is a condition that makes it hard to speak, understand, read, or write after a stroke or other brain injury.

What is tVNS?

tVNS is a gentle electrical stimulation applied to a nerve in the ear using a small device, which is non-invasive and safe.

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

No, you won't know if you're getting the active device or a 'sham' (inactive) device. This helps us ensure the study results are fair.

How long will I be involved in the study?

Your active participation, using the device and doing therapy, will last for six weeks.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Dr Ali Ali

ali.ali@sheffield.ac.uk 01142159114 Official trial record

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