RecruitingOBSERVATIONAL

White Matter Distortion and Dementia Biomarkers in Normal Pressure Hydrocephalus (NPH)

This study focuses on Normal Pressure Hydrocephalus (NPH), a condition that can cause problems with walking, memory, and bladder control in older people. Sometimes, a surgery to drain excess fluid from the brain (called a shunt) can help a lot, but for others, it doesn't. We're trying to find out why. We'll look closely at brain scans to see if certain brain pathways are damaged differently in those who get better after surgery. We're also checking for signs of other memory-related illnesses. The study will explore if wearing activity trackers and taking memory tests on a tablet could help doctors understand how people are doing and if they are improving after treatment. Ultimately, we hope to improve how NPH is diagnosed and treated.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

100

Start

25 Mar 2025

Estimated completion

01 Feb 2029

Normal Pressure Hydrocephalus

What is this study about?

You've been diagnosed with Normal Pressure Hydrocephalus (NPH), a condition where too much fluid builds up around the brain. This can lead to difficulties with walking, thinking, and bladder control. Sometimes, a special operation called a shunt helps drain this extra fluid, and many people feel much better afterwards. However, for some, the surgery doesn't have the same positive effect, and doctors aren't always sure why.

This study aims to get a clearer picture of what's happening in the brains of people with NPH. We want to understand why some patients respond well to the shunt surgery and others don't. We will be carefully examining how certain pathways in the brain (often called 'white matter') are affected. We're also checking to see if other memory problems, similar to dementia, might be present which could explain why some shunt surgeries aren't as successful.

We also want to see if new technologies, like wearable activity trackers and digital memory tests, could be useful tools for you and your doctors. These tools might help track your progress at home and give a better idea of how your quality of life is changing. By doing all this, we hope to learn more about NPH and find better ways to help people like you in the future.

Key takeaways

Aims to understand why shunt surgery works for some NPH patients but not others.
Investigates brain changes and other memory problems in NPH.
Tests new digital tools for monitoring health and progress at home.
Will involve hospital visits, special scans, and some sample collections.
Participation is voluntary and will not affect your medical care.

Who may be eligible?

This study is looking for two main groups of people. The first group includes adults over 60 who have NPH and are experiencing walking difficulties, memory problems, or bladder issues. For this group, it's important that your hydrocephalus isn't caused by a head injury or infection, and that you're well enough to consider shunt surgery and attend hospital visits.

The second group of people are needed as 'controls'. This includes healthy individuals, such as carers or staff, and also people with other types of hydrocephalus that aren't causing symptoms, or people with other memory conditions like Alzheimer's or vascular dementia. The main thing is that everyone involved must be able to come to the hospital for study visits.

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 60 years old or older?
Do you have problems with walking, memory, or bladder control?
Has a doctor told you that you have Normal Pressure Hydrocephalus (NPH)?
Are you well enough to attend hospital appointments and potentially consider surgery?
Do you not have hydrocephalus caused by a recent head injury or infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be followed by the study team from your first assessment all the way through to a decision about shunt surgery, and after if you have the surgery. You'll have several hospital visits where doctors will do a full check-up, including looking at your walking, thinking, and bladder function. You'll also be asked about your general well-being and quality of life.

Some of the tests will involve blood samples and a spinal tap (lumbar puncture) to collect fluid around your spine. You will also have special detailed MRI scans of your brain. There are also optional parts, which include a small brain biopsy (removing a tiny piece of brain tissue during surgery, if you're having it) and a skin biopsy. You'll be asked to wear a special activity tracker and sleep monitor, and also try out some memory tests on a digital device at home. The study will follow your progress and changes over time, and the total duration will depend on your individual clinical journey.

Potential risks and benefits

Participating in this study might help us learn more about NPH, which could lead to better ways of diagnosing and treating the condition in the future. While this study is not designed to directly treat your NPH, the information gathered from your tests and observations might provide your doctors with a deeper understanding of your condition. Some procedures, like blood tests, spinal taps, and biopsies, carry small risks like bruising, headache, or infection, and these will be explained in detail. You are free 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.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is NPH?

NPH stands for Normal Pressure Hydrocephalus. It's a condition where extra fluid builds up around the brain, often causing problems with walking, thinking, and bladder control in older people.

What is a 'shunt' operation?

A shunt is a small tube surgically placed to drain excess fluid from the brain to another part of the body, usually the tummy, where it can be safely absorbed.

Will I have to take any new medicines?

No, this study is about observing your condition and how you respond to your usual care, not about testing new medicines.

What is a brain biopsy?

A brain biopsy is a procedure where a very small piece of brain tissue is carefully removed for examination. In this study, it's an optional part, and would only be done if you are already having brain surgery for your NPH.

How long will I be in the study?

The study will follow your clinical journey, from your initial assessment up until a decision is made about shunt surgery, and then afterwards if you have the surgery. The exact duration will vary for each person.

How to find out more

Chris Carswell

NPH@imperial.ac.uk +44 20311 1234 Official trial record

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