RecruitingNAINTERVENTIONAL

Investigating the Tolerability and Feasibility of tVNS Following aSAH

This study is for adults who have had a brain bleed called a subarachnoid haemorrhage. Researchers want to see if a treatment called Transcutaneous Vagus Nerve Stimulation (tVNS) can help reduce problems after this type of bleed. tVNS uses a small device attached to an earpiece to gently stimulate nerves, which has been safely used for other health issues. Participants will receive either active tVNS or a dummy version twice a day for five days. The study will check if this treatment is safe, easy to use, and if it shows any signs of preventing complications. All participants will continue to receive their usual medical care.

At a glance

Status

Recruiting

Phase

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

17 Apr 2024

Estimated completion

31 Jul 2026

Subarachnoid Haemorrhage From Cerebral Aneurism Rupture

What is this study about?

This study is looking into new ways to help people recover after a serious type of brain bleed, called a subarachnoid haemorrhage. This can happen when a weak spot in a blood vessel in the brain bursts. While doctors do their best to treat and prevent problems, complications like further damage to the brain are quite common and can affect a person's recovery.

Now, researchers are exploring if a treatment called Transcutaneous Vagus Nerve Stimulation (tVNS) could make a difference. tVNS uses a small, handheld device connected to an earpiece to gently stimulate nerves near the ear. This kind of stimulation has been used safely for other conditions like headaches and seizures, and it's thought that it might help improve blood flow and reduce swelling in the brain.

For this study, the main goal is to find out if tVNS is safe and comfortable for people who have recently had a subarachnoid haemorrhage. They also want to see if there are any early signs that it could help reduce the risk of further problems. This research is important because if tVNS proves to be helpful, it could lead to better treatments and improved outcomes for people affected by this condition in the future.

Key takeaways

This study investigates a new treatment (tVNS) for reducing complications after a brain bleed.
tVNS involves gentle electrical stimulation near the ear, typically used for other conditions.
Participants will receive either active tVNS or a dummy version for 5 days.
The main goals are to check if tVNS is safe, easy to use, and shows signs of helping.
You will continue to receive all standard medical care during the study.
Side effects are usually mild, like tingling, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years or older and a patient in the neurosurgery department at Sheffield Teaching Hospital. You also need to have been diagnosed with a specific type of brain bleed (called an aneurysmal subarachnoid haemorrhage) that has been treated within the last five days.

There are also some reasons why you wouldn't be able to join. These include if you have a pacemaker, another type of electrical stimulator in your body, or certain heart conditions like very slow heart rate. You also can't have used a vagus nerve stimulation device before.

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.

Am I 18 years old or older?
Am I currently a patient in the neurosurgery department at Sheffield Teaching Hospital?
Have I had a confirmed aneurysmal subarachnoid haemorrhage (a specific type of brain bleed)?
Was my brain bleed treated (coiled or clipped) within the last five days?
Do I have a pacemaker or any other electrical stimulator in my body?
Do I have any heart conditions like very slow heart rate?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of 30 participants. Before the study begins, the research team will collect some information about your health, including your diagnosis, current medicines, age, and some blood test results. You'll also complete a few simple questionnaires about your symptoms, and they'll measure your heart rate, how your pupils react, and your brain activity using a special cap.

Then, you'll be randomly chosen to receive either the active tVNS treatment or a 'sham' version that looks and feels similar but doesn't deliver the active stimulation. For five days, a team member will apply the earpiece to your ear for 45 minutes, twice a day. You will still receive all your usual medical care and observations throughout this time.

After these five days, the main treatment part of the study is over. However, the researchers will arrange follow-up meetings at the time you leave the hospital and again at six weeks later to check on your symptoms and how you are recovering.

Potential risks and benefits

The potential benefit of taking part is that tVNS might help reduce complications and improve recovery after a brain bleed, although we are still studying if it works in this situation. Previous studies have shown that tVNS is generally safe and well-tolerated. The most common side effects are mild, like tingling, numbness, pain, or redness around the ear, headaches, or dizziness. Rarely, it might cause your heart to beat faster or slower. You will continue to receive all your usual medical care and observation. Remember, you can choose to leave the study at any time if you feel it's too much for you, and this will not affect your medical care.

Locations (1)

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

University of Sheffield
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is a subarachnoid haemorrhage?

It's a serious type of bleeding on the surface of the brain, often from a burst blood vessel.

What is tVNS?

It's a gentle electrical stimulation applied near the ear with a small device, aiming to affect brain function.

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

No, you won't know because you'll be randomly assigned to either the active tVNS or a 'sham' (dummy) version.

How long will the treatment part of the study last?

The active treatment phase involves a device being applied twice a day for 45 minutes, over five days in total.

What happens if I want to stop participating?

You are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Dr Ali Ali

ali.ali@sheffield.ac.uk +4401142159114 Official trial record

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