RecruitingOBSERVATIONAL

Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project

The VESPAR Project is an observational study exploring how blood flow in the brain is linked to conditions like stroke, dementia, depression, and delirium. The main goal is to figure out if special brain scans, using Transcranial Doppler Ultrasonography and Near Infrared Spectroscopy, can spot changes in how the brain regulates its blood supply and how brain activity is connected to blood flow. By doing this, researchers hope to understand these conditions better and work out the best ways to test people. They also want to use the information gained to plan larger studies in the future and create models for understanding more about these health issues.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

140

Start

17 Mar 2023

Estimated completion

26 Aug 2026

Cognitive Dysfunction Stroke Dementia Depression Delirium

What is this study about?

The VESPAR Project is a research study looking at how blood flow and activity in your brain might be connected to conditions like stroke, dementia (which causes memory and thinking problems), depression, and delirium (a sudden state of confusion). Researchers want to find out if special tests can show changes in how your brain controls its blood supply and how blood flow changes when your brain is working. Think of it like a finely tuned engine: if the fuel delivery isn't quite right, the engine won't run as well.

The main idea is to see if these tests, called Transcranial Doppler Ultrasonography and Near Infrared Spectroscopy, are good ways to measure these brain changes across different groups of people – those who are healthy, and those with stroke, dementia, depression, or delirium. The information learned from these measurements will help the researchers understand what's normal and what's different in these conditions. This is an exploratory study, meaning it's a first step to gather important information. They're not testing a new treatment, but rather trying to understand the body better.

Ultimately, by gathering this detailed information, the team hopes to work out the best ways to test people in future, larger studies. They also want to develop advanced computer models to help predict how these brain blood flow changes might affect someone's health over time. This foundational work is really important for developing better ways to diagnose and help people with these conditions in the future.

Key takeaways

The VESPAR Project investigates brain blood flow in dementia, stroke, depression, and delirium.
It uses special tests (ultrasound and light sensors) to measure brain blood flow.
The study helps researchers plan better studies for the future.
Participation involves one visit for measurements and questionnaires.
It's an observational study, so no new treatments are given.
You can withdraw at any time without affecting your care.

Who may be eligible?

To join this study, you would generally need to be 65 years old or older. The study is looking for a few different groups of people.

Firstly, healthy adults who are over 65 and don't have serious medical problems or take medications that affect their thinking or brain blood flow. If you have well-managed health conditions, like high blood pressure that's under control, you might still be able to take part.

They also want to include people who have a formal diagnosis of dementia, depression, or delirium, based on specific medical guidelines. This includes people taking medications for dementia or depression, and those who are not. If you've recently had a stroke (either an ischaemic stroke or a haemorrhagic stroke) within the last three days, verified by doctors, you might also be suitable. However, if you have severe or uncontrolled medical conditions that affect your brain or health, are too unwell to take part, or can't give your consent, then this study wouldn't be suitable 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 65 years old or older?
Do you have a diagnosis of dementia, depression, or delirium?
Have you had a stroke within the last three days?
Are you generally in stable health and able to cooperate with assessments?
Can you understand and give consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to visit the research lab at Leicester Royal Infirmary for one assessment. However, if you have delirium, the assessment will happen on your hospital ward to make sure you're comfortable. For stroke patients, the research team will decide if it's best for you to be assessed in the lab or on the ward, based on your individual needs. Before you take part, the team will check that you're able to understand and agree to participate in the study under UK law.

During the assessment, several measurements will be taken. You'll have two recordings of your brain's blood flow using a special ultrasound test called transcranial Doppler ultrasonography, along with your blood pressure, breathing (CO2 levels), and heart rate. One recording will be taken while you rest for 5 minutes. The second recording, lasting about 15 minutes, will involve some simple activities like thinking, moving, sensing things, and looking at things on a screen. You'll also have sensors on your forehead to measure oxygen levels in your brain. Afterwards, you might be asked to fill in some questionnaires about your memory, mood, and any confusion, if these haven't already been covered in your medical checks. If you've had a stroke, there will be a couple of extra questionnaires about your stroke severity and how easily you can do daily tasks.

Some suitable participants might also be invited to do an extra assessment where the brain blood flow tests are done while you do a balance assessment, looking at how steady you are in different situations, including with your eyes. This would be either during your main assessment or at a separate time.

Potential risks and benefits

Taking part in this study may offer some benefits, such as helping researchers better understand conditions like stroke, dementia, depression, and delirium. The information gathered could contribute to future improvements in diagnosis and care, although there are no direct health benefits to you personally from taking part. The risks of participation are generally low. The tests used, like the ultrasound and sensors, are common and non-invasive. You might find the questionnaires tiring, or the testing environment a little unfamiliar. However, your comfort and safety are a priority, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting
Leicestershire Partnership Trust
Verified postcode
Leicester, United Kingdom· Not yet recruiting

Common questions

What is the main purpose of the study?

To explore how blood flow in the brain is connected to conditions like stroke, dementia, depression, and delirium, and to find the best ways to measure these changes for future research.

Will I get any new medicine or treatment?

No, this is an observational study, meaning researchers are observing and measuring things. You will not receive any new treatments or medicines as part of this study.

How long will the assessment take?

The main part of the assessment will involve two recordings, one 5-minute and one 15-minute, plus time for questionnaires. The total time for the assessment will be explained fully by the study team.

Where will I need to go for the study?

Most participants will come to a research lab at Leicester Royal Infirmary. If you have delirium or are a stroke patient, the assessment might happen on your hospital ward for your comfort.

Can I stop taking part if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

James Ball

jdb58@le.ac.uk 07551300119 Official trial record

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