RecruitingOBSERVATIONAL

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

This study focuses on degenerative ataxia, a condition affecting balance and movement, that appears in adults without a family history. Researchers want to compare two types: cerebellar multiple system atrophy (MSA-C) and sporadic adult onset ataxia of unknown cause (SAOA). The main goals are to see how these conditions develop differently, how fast they get worse, and what factors might predict which type a person has. The study also aims to figure out when doctors can reliably tell the two conditions apart. Blood samples will be collected for future research into genes and other indicators of the disease. This helps us better understand these complex conditions.

At a glance

Status

Recruiting

Sponsor

Ataxia Study Group

Enrolment target

300

Start

01 Apr 2010

Estimated completion

01 Dec 2030

Late Onset Sporadic Cerebellar Ataxia

What is this study about?

This research is looking into a condition called ataxia. Ataxia affects your coordination, balance, and speech, making everyday tasks difficult. When it starts in adulthood without a clear family link, doctors often call it 'sporadic degenerative ataxia'. This study focuses on two main groups within this type of ataxia: one is called 'multiple system atrophy of cerebellar type' (MSA-C), and the other is 'sporadic adult onset ataxia of unknown aetiology' (SAOA).

Doctors sometimes find it hard to tell the difference between these two conditions, especially in the early stages. MSA-C often involves other problems like issues with blood pressure regulation or bladder control, while SAOA typically doesn't have these extra issues. This study wants to follow patients over time to see how the conditions progress, how quickly they change, and what early signs might point towards one diagnosis over the other. Understanding these differences will help doctors make more accurate diagnoses sooner and improve future care.

Another important part of this study is collecting blood samples and other biological materials from participants. These samples will be stored and used for future research. Scientists hope to discover more about the genetic factors involved and find specific 'biomarkers' – substances in the body that can indicate the presence or progression of a disease. This kind of research is crucial for developing new tests and treatments in the future.

Key takeaways

This study helps understand adult-onset ataxia without a family history.
It aims to tell the difference between two types: MSA-C and SAOA.
No new treatments will be given; it's about observation.
Your participation helps future research into causes and treatments.
Blood samples are collected for genetic and biomarker studies.

Who may be eligible?

To join this study, you need to have a type of ataxia that is gradually getting worse, and it must have started after your 40th birthday. Also, there shouldn't be any similar conditions that run in your immediate family or close relatives. Your parents should have lived past 50, or if they passed away earlier, ensure it wasn't due to a similar condition.

There are also reasons why you might not be able to join. For example, if your ataxia is linked to things like a stroke, severe infection, alcohol misuse, certain medications, or other specific illnesses like some cancers or uncontrolled diabetes, then this study might not be suitable for you. Doctors will also check that your ataxia hasn't developed very quickly (within three months).

Finally, various medical test results, including brain scans and blood tests, will be reviewed. These checks help make sure your condition fits the specific type of ataxia the study is focused on, ruling out other known causes like multiple sclerosis or certain genetic conditions. Your doctors will explain all these details to ensure the 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.

Is your ataxia getting worse over time?
Did your ataxia start after your 40th birthday?
Do you have no close family members with similar conditions?
Have other causes for your ataxia (like stroke, alcohol, or certain infections) been ruled out?
Are your brain scans and blood tests consistent with sporadic ataxia?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to visit the study clinic regularly over a period of time. During these visits, doctors will perform examinations and assessments to monitor your symptoms and how your balance and coordination are changing. They will also ask you questions about your health and how you are feeling. You will likely have blood samples taken at these visits, as well as possibly other samples like urine or spinal fluid, for further analysis.

The study is focused on observing the natural progression of these conditions, so you won't be given any new experimental medication as part of this research. You will continue to receive your usual medical care from your own doctors. The total duration of your participation will depend on the study design, but generally, natural history studies involve following participants for several years to track long-term changes. You'll be given a clear schedule of visits and what to expect at each one.

Potential risks and benefits

Taking part in this study might not directly benefit you, as it's an observational study designed to gather information rather than test a new treatment. However, by participating, you will be contributing vital knowledge that could help doctors better understand these conditions and improve diagnosis and care for future patients. The main risks involve the procedures like blood tests, which might cause minor discomfort, bruising, or a small risk of infection. You might also find the regular clinic visits tiring, and some of the questions could be upsetting for some people. It's very important to remember that joining a clinical study is completely voluntary, and you have the right to withdraw at any time without explaining why. This decision will not affect your ongoing medical care.

Locations (14)

Department of Neurology, Medical University, Innsbruck
Verified postcode
Innsbruck, Austria· Active not recruiting
Universitätsmedizin Berlin Charité
Verified postcode
Berlin, Germany· Recruiting
Department of Neurology, University of Bonn
Verified postcode
Bonn, Germany· Recruiting
Department of Neurology, University Clinic Essen, University of Duisburg-Essen
Verified postcode
Essen, Germany· Recruiting
Department of Neurology, University of Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
Hamburg UKE Abt. Neuropädiatrie
Verified postcode
Hamburg, Germany· Active not recruiting
Otto-von-Guericke Universität Magdeburg
Verified postcode
Magdeburg, Germany· Recruiting
Friedrich-Baur-Institut an der Neurologischen Klinik
Verified postcode
München, Germany· Recruiting
Universitätsmedidzin Rostock - Klinik und Poliklinik für Neurologie
Verified postcode
Rostock, Germany· Recruiting
Dept. of Neurodegenerative Diseases Tübingen
Verified postcode
Tübingen, Germany· Recruiting
Department of Neuroscience, Federico II University Naples
Verified postcode
Naples, Italy· Recruiting
Universita cattolica del sacro cuore
Verified postcode
Rome, Italy· Active not recruiting

Common questions

What is 'ataxia'?

Ataxia is a medical term for problems with coordination, balance, and speech, making movements clumsy and difficult.

What does 'sporadic adult onset' mean?

It means the condition starts in adulthood and doesn't seem to be inherited from your family.

Will I get a new treatment in this study?

No, this study is about observing how the condition progresses naturally, so you won't receive new experimental treatments.

Why are blood samples needed?

Blood samples help researchers look for genetic clues and 'biomarkers' that could tell us more about the disease and potentially lead to new tests or treatments.

How long will I be in the study?

The study aims to follow people over several years to observe how their condition changes over time. Your study team will give you a specific timeline.

How to find out more

Ilaria Anna Giordano, MD

ilaria_anna.giordano@ukb.uni-bonn.de 0049 228 287 15750 Official trial record

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