RecruitingOBSERVATIONAL

Synaptic Loss in Multiple System Atrophy

This study aims to understand what happens in the brains of people with Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP). For MSA, researchers are using special brain scans to see how tiny connections between brain cells, called synapses, are damaged and how early this damage occurs. This is important because synapses are vital for brain communication, and there's currently no cure for MSA. For PSP, and to help tell the difference between MSA and PSP, the study will also look at a protein called tau, which builds up abnormally in PSP. By using these advanced scanning techniques, the researchers hope to learn more about these conditions and improve diagnosis in the future.

At a glance

Status

Recruiting

Sponsor

University of Exeter

Enrolment target

Start

01 Sep 2021

Estimated completion

31 Mar 2027

Multiple System Atrophy Progressive Supranuclear Palsy (PSP)

What is this study about?

This study is looking into two conditions that affect the brain: Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP). MSA is a serious illness that gets worse over time, and unfortunately, there's no cure at the moment. In people with MSA, tiny connections in the brain called 'synapses' get damaged. These synapses are like the communication lines between brain cells, and they're essential for everything your brain does. The researchers want to find out exactly how and when this damage happens in MSA, hoping that understanding this better could lead to new ways to help patients.

To do this, they will use special brain scans. One type of scan, called a PET scan, uses a tiny amount of a safe substance to show how healthy these synapses are. They'll also use other scans like an MRI, which provides detailed pictures of your brain, and another PET scan to check your brain's energy use. Some people taking part might also be asked to have a lumbar puncture, which involves taking a small sample of fluid from around your spinal cord; this is completely optional.

The study also includes a separate part looking at a different condition called Progressive Supranuclear Palsy (PSP). Sometimes it can be very difficult for doctors to tell the difference between MSA and PSP just from looking at symptoms. In PSP, a different protein called 'tau' builds up in the brain. The researchers hope that another special PET scan, which can detect this tau protein, might help doctors distinguish between MSA and PSP more clearly. This could lead to better and earlier diagnosis for both conditions.

Key takeaways

This study investigates brain changes in Multiple System Atrophy (MSA) and Progressive Supranucler Palsy (PSP).
It uses special brain scans to look at brain cell connections (synapses) in MSA and a protein called tau in PSP.
Understanding these changes could help improve diagnosis and future treatments.
Participation involves clinic visits, symptom questionnaires, and specific brain scans (PET, MRI).
A voluntary lumbar puncture may also be offered to some participants.
The study aims to contribute to scientific knowledge, not to provide direct personal treatment.

Who may be eligible?

To be considered for the main part of the study (the MSA group), you should be between 45 and 80 years old. You must have a diagnosis of probable or possible Multiple System Atrophy (MSA). If you are a woman who can have children, you must not be pregnant or breastfeeding, and you'll need to use an effective method of birth control during the study. If you are a man with a partner who can have children, you'll also need to use specific birth control methods for a time after each scan.

It's important that you fully understand what the study involves and are happy to sign a consent form. You should also be able to attend all appointments and follow all study instructions. The doctors also need to believe that you are likely to live for at least three more years. Any existing health conditions you have, and the medications you take for them, should be stable and unchanged for at least 30 days before the study begins.

For the PSP subgroup, specific criteria will apply, which will be discussed if you are considered for that part of the study.

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 between 45 and 80 years old?
Do you have a diagnosis of probable or possible Multiple System Atrophy (MSA)?
Are you able to attend all study appointments?
If you are a woman of childbearing potential, are you using an effective form of birth control and not pregnant or breastfeeding?
Have your medical treatments been stable for at least 30 days?
Are you willing and able to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll have an initial visit where you'll answer questions about your health and complete some symptom questionnaires. After that, you will have several types of brain scans: a special PET scan to look at brain connections (synapses), another PET scan to check your brain's energy, and an MRI scan for detailed brain pictures. You might also be asked to have a lumbar puncture, which involves taking a small fluid sample from your spine, but this is optional and not required to participate.

Some people with MSA who are in the main study might also be asked to have one additional PET scan to look at a protein called tau. Separately, if you have PSP, you will have a clinic visit with tests, a blood sample taken, an MRI scan, and one PET scan looking for the tau protein. The study's total duration for these parts will vary depending on your group, with the PSP group potentially having a follow-up visit after about a year.

Potential risks and benefits

Participating in this study might not directly improve your condition, but the information gained could greatly help future patients by improving our understanding and diagnosis of MSA and PSP. There are some risks involved, including those associated with scans like PET and MRI, and the lumbar puncture (if you choose to have it). These procedures involve a small amount of radiation exposure from PET scans, and some discomfort from injections or the optional lumbar puncture. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

University of Exeter
Verified postcode
Exeter, United Kingdom· Recruiting

Common questions

What is a synapse?

Synapses are tiny connections between brain cells that allow them to communicate with each other. They are vital for how your brain works.

What is a PET scan?

A PET scan is a special type of brain scan that uses a tiny amount of a safe, temporary substance to show how your brain cells are working or to highlight specific changes, like damage to synapses or protein build-up.

What is a lumbar puncture?

A lumbar puncture (also known as a spinal tap) is a procedure where a doctor carefully takes a small sample of the fluid surrounding your brain and spinal cord, which can provide important information about your brain health. It is optional for this study.

Will this study cure my condition?

This study is for research and aims to improve our understanding of MSA and PSP. It is not designed to cure your condition, but the knowledge gained could lead to better treatments in the future.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your usual medical care.

How to find out more

Edoardo R. de Natale, MD MSc Ph.D

e.de-natale@exeter.ac.uk 07503741242 Official trial record

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