RecruitingNAINTERVENTIONAL

EEG Monitoring for Refractory Status Epilepticus

This study is investigating a special type of brain monitoring called continuous EEG (cEEG) for patients in intensive care (ICU) who are experiencing severe, ongoing seizures that haven't responded to initial treatments (Refractory Status Epilepticus). The main goal is to find out if using cEEG can help reduce the amount of time people spend in the hospital, lower the risk of complications like infections, and ultimately improve their quality of life after going home, compared to standard medical care. This is an initial, smaller study to gather important information that will help researchers plan a larger study in the future. It will also help ensure the study process is smooth and understand the costs involved.

At a glance

Status

Recruiting

Phase

Sponsor

Barts & The London NHS Trust

Enrolment target

Start

17 Mar 2020

Estimated completion

31 Jul 2027

Status Epilepticus

What is this study about?

This research study is looking at how a special type of brain monitoring, called a continuous electroencephalogram (cEEG), might help people who are very unwell with severe, ongoing seizures. These seizures are called 'Status Epilepticus' and they haven't stopped with the usual first treatments. This makes them 'refractory', meaning they are hard to control.

When someone has these severe seizures, they often need to be in the intensive care unit (ICU). Doctors want to see if using a cEEG machine to constantly watch brain activity can make a real difference. They hope it might help patients spend less time in the hospital, avoid problems like infections or bedsores, and lead to a better quality of life once they go home. Current treatments involve regular, but not continuous, checks of brain activity.

Because this is a new idea that hasn't been studied much before, this is a smaller, first-stage study. It's designed to gather initial information on how well cEEG works and to ensure that the study can be run smoothly and safely for a bigger research project later. It will also help understand the resources needed to provide this kind of monitoring.

Key takeaways

This study is for adults in ICU with severe, ongoing seizures.
It compares continuous brain monitoring (cEEG) with standard care.
Aims to see if cEEG reduces hospital time and improves recovery.
This is a small, initial study to prepare for a larger one.
Participation means being randomly assigned to one of two care groups.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults aged 16 and over. You might be able to take part if you are in the intensive care unit (ICU) because you are experiencing severe, ongoing seizures known as Status Epilepticus.

These seizures must be serious enough that they haven't stopped after you've been given emergency medication (like benzodiazepines) and at least one other anti-seizure medicine. The seizures can be either obvious, like shaking, or less obvious, where your consciousness is affected without clear physical jerking.

However, you won't be able to join the study if your seizures are caused by a severe lack of oxygen to the brain, which can happen after a cardiac arrest or other serious incident.

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 16 years old or older?
Are you currently in intensive care (ICU) due to ongoing seizures?
Have your seizures continued despite initial medication?
Are your seizures NOT caused by a severe lack of oxygen to your brain?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly placed into one of two groups. One group will receive standard care, which means doctors will check your brain activity with an EEG machine whenever they think it's needed. The other group will have continuous EEG (cEEG) monitoring, where your brain activity is watched constantly until 24 hours after your seizures have completely stopped.

All patients in the study, regardless of their group, will receive care from the same medical team following the same treatment guidelines. The researchers will collect information from your medical records, including details about your age, background, and medical history. They will also track how long you stay in the hospital, any complications you develop, and your recovery after you leave. There will be follow-up checks at 3, 6, and 12 months after you leave the hospital, likely through reviewing your medical notes or by appointment where your quality of life will be assessed.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving continuous monitoring of your brain activity, which could lead to more immediate adjustments to your treatment. For others, knowing you are contributing to medical knowledge to help future patients can be a benefit. Potential risks of continuous monitoring could include skin irritation from the electrodes or the practical challenges of having equipment attached for an extended period. Some patients may feel concerned about the continuous nature of the monitoring. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'Status Epilepticus'?

It's a medical emergency where seizures last for a long time, or one seizure quickly follows another, without the person fully recovering in between.

What is an EEG?

An EEG (electroencephalogram) is a test that measures the electrical activity of your brain using small sensors placed on your scalp. It helps doctors detect seizures.

What's the difference between regular EEG and continuous EEG (cEEG)?

Regular EEG is done for a short time, while continuous EEG monitors your brain activity constantly over a longer period, often days, to make sure no small seizures are missed.

Why is this only a 'feasibility study'?

It's a smaller, initial study to see if the approach is practical and to gather enough early information to decide if a larger, more detailed study should be done in the future.

Will I definitely get the continuous monitoring if I join?

No, you will be randomly assigned to either receive continuous monitoring or standard care (EEG tests done as needed). This is like tossing a coin.

How to find out more

Vasiliki Tsirka, Consutlant

vasiliki.tsirka@nhs.net 00447407781374 Official trial record

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