Active not recruitingOBSERVATIONAL

Ultra-long-term EEG Monitoring in PwID

This study is testing a small device that goes just under the skin on the head to monitor brain activity in people with mild to moderate intellectual disabilities (ID) who experience seizures. Seizures can be hard to spot in people with ID, and this device offers a new way to track them without needing hospital stays. Researchers want to see if the device accurately picks up seizures, how safe it is, and if it improves the quality of life for participants. They will also gather feedback from carers and healthcare staff about using the device. The goal is to find a better, less disruptive way to understand and manage seizures for this group.

At a glance

Status

Active not recruiting

Sponsor

University of Plymouth

Enrolment target

Start

12 Oct 2024

Estimated completion

31 Mar 2026

Epilepsy Intellectual Disability, Mild to Moderate

What is this study about?

This research project is looking at a new, very small device designed to sit just under the skin on a person's head. Its purpose is to track the electrical activity in the brain, which is how we detect seizures. This type of brain activity monitoring, called EEG, can be tricky for people with intellectual disabilities (ID) because traditional methods often involve hospital stays and can be uncomfortable.

The developers of this device, UNEEG medical, have already seen it work well for up to 15 months in other people with seizures, but it hasn't been tested specifically in those with intellectual disabilities. Because people with mild to moderate ID might find it harder to describe their experiences, seizures can sometimes be missed or mistaken for other issues. This device could offer a clearer picture of what's happening, helping doctors provide better care.

The project will involve comparing the information from the device with notes kept by carers about seizures. Researchers will also look at whether the device is safe, how it affects a person's behaviour and daily life, and what carers and medical professionals think about using it. They'll also consider the potential benefits and costs of using this system more widely in the future.

Key takeaways

A new device is being tested for long-term seizure monitoring.
It's designed for people with mild to moderate intellectual disabilities.
The device goes under the skin on the scalp to track brain activity.
The study aims to check its accuracy, safety, and impact on daily life.
Carers and healthcare staff experiences are also a key part of the research.
Participants must be able to give their own consent.

Who may be eligible?

To join this study, participants need to be adults over 18 years old. They must have a diagnosis of epilepsy that hasn't responded well to standard treatments, and also have a mild to moderate intellectual disability. Importantly, they need to be able to understand what the study involves and agree to take part themselves.

Participants should also be able to comfortably wear a practice device for a short period before the main device is implanted. We would also need their family members or carers to be willing to keep a record of any possible seizure-like events and to provide some past information about these occurrences. These events should be happening at least once a month, though it's okay if they're not sure if they are definite seizures or other behavioural issues.

Finally, the participant's epilepsy specialist would need to recommend them for this type of long-term brain activity monitoring. If you fit these descriptions and are interested, your medical team can discuss if this study is right for you.

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 over 18 years old?
Have you been diagnosed with epilepsy that's hard to control with medicines?
Do you also have a mild to moderate intellectual disability?
Are you able to understand and agree to take part in the study yourself?
Do you experience at least one possible seizure or unusual event each month?
Would your family/carer be able to help keep a diary of these events?

Answer every question to see your result.

What does participation involve?

If you are found to be suitable and you agree to join the study, you would have the small UNEEG SubQ device placed under the skin on your scalp. This is a minor procedure. After the device is in, it will continuously record your brain activity. This information will be regularly collected and looked at alongside a diary of any seizures or unusual events kept by your family or carer.

You would also be asked to complete some questionnaires about your quality of life and any behaviour changes. These would be done before the device is put in, and then again shortly after, and at three and six months later. Finally, you, your carers, and your healthcare team would be invited to take part in group discussions to share your experiences and thoughts about the device and how it’s worked out. The total duration of active participation in the study is planned for six months.

Potential risks and benefits

Participating in this study could potentially offer a clearer understanding of your seizures, helping your medical team to manage them better without the need for frequent hospital visits. However, as with any medical procedure, there are some potential risks. These could include minor discomfort or a small risk of infection from the device implantation, though all efforts will be made to minimise these. Your quality of life questionnaires and group discussions help us understand any impact, positive or negative. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Cornwall Partnership NHS Foundation Trust
Verified postcode
Truro, United Kingdom

Common questions

What is EEG monitoring?

EEG stands for electroencephalography. It's a way to measure the electrical signals in your brain, which helps doctors understand your brain activity and diagnose conditions like epilepsy.

What is the 'SubQ' device?

The 'SubQ' device is a very small monitor designed to be placed just under the skin on your head. It continuously tracks your brain's electrical activity to detect seizures over a long period.

Will I need to stay in hospital?

The main benefit of this device is that it's designed to monitor you at home, avoiding the need for long hospital stays that are often required for traditional EEG monitoring.

What does 'capacity to consent' mean?

It means you are able to understand the information about the study and make a clear, informed decision about whether you want to take part yourself.

Who is eligible to participate?

Adults over 18 with a mild to moderate intellectual disability and epilepsy that hasn't responded well to treatment, who can agree to join the study, and have monthly seizure-like events are among those who might be eligible.