RecruitingOBSERVATIONAL

Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry

This study aims to better understand nerve conditions, like small fibre neuropathy and autonomic neuropathy, and Ehlers-Danlos syndromes. Researchers are comparing people with these conditions to healthy volunteers to learn how the illnesses develop over time and what causes them. They're particularly interested in small fibre neuropathy. As part of the study, participants will have a number of tests, including blood tests, questionnaires about their health, and checks on how their body responds to changes in position. These checks will happen at the beginning of the study, after three months, and again after a year and a half. The ultimate goal is to improve how these conditions are diagnosed and managed in the future for people in clinics.

At a glance

Status

Recruiting

Sponsor

RWTH Aachen University

Enrolment target

200

Start

15 Sep 2019

Estimated completion

15 Sep 2029

Autonomic Neuropathy Ehlers-Danlos Syndrome Hypermobility Type Small Fiber Neuropathy Postural Tachycardia Syndrome

What is this study about?

This study is called "Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry." It's being conducted to learn more about a group of conditions that affect the body's small nerves and how they control automatic functions, like heart rate, digestion, and sweating. These conditions are sometimes called "autonomic neuropathies" or "small fibre neuropathies." The study also includes people with Ehlers-Danlos syndromes, especially the hypermobility type, as these can sometimes be linked to nerve problems.

Researchers want to understand how these conditions progress over time and what causes them. By comparing people with these conditions to healthy volunteers, they hope to gain important insights into the underlying problems. They're also looking to improve how doctors diagnose these conditions, especially in regular clinics, by testing a German version of a scoring system for Postural Tachycardia Syndrome (POTS), a condition where your heart rate speeds up too much when you stand up.

Essentially, the study aims to build a clearer picture of these complex conditions. By gathering detailed information over a period of 18 months, researchers hope to improve our understanding, which could lead to better ways to diagnose and help people living with these health challenges in the future.

Key takeaways

The study aims to understand nerve and Ehlers-Danlos conditions better.
It involves comparing people with these conditions to healthy volunteers.
You'll have three check-ups over 18 months, with various tests.
No new treatments are given; you continue with your usual care.
Your participation could help improve diagnosis and care for others.
You must be 18-80 years old and speak German to be eligible.

Who may be eligible?

To be considered for this study, you generally need to be between 18 and 80 years old. You might be eligible if you have certain nerve conditions like autonomic neuropathy or Postural Orthostatic Tachycardia Syndrome (POTS). People with hypermobile or classical Ehlers-Danlos syndromes are also welcome to apply.

Additionally, the study is open to individuals with Chronic Fatigue Syndrome, Mast Cell Activation Syndrome, or Post-COVID syndrome. They are also looking for healthy volunteers who do not have these conditions to help compare the results. You'll need to be able to speak German.

However, there are some reasons why you wouldn't be able to join. For example, if you are pregnant, have a pacemaker or deep brain stimulation device, or if you have certain other nerve diseases that affect larger nerves or degenerative brain conditions.

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 18 and 80 years old?
Do you have an autonomic neuropathy or Postural Orthostatic Tachycardia Syndrome (POTS)?
Do you have hypermobile or classical Ehlers-Danlos syndrome?
Can you speak German?
Are you NOT pregnant and don't have a pacemaker or specific other nerve conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given any new medications or treatments beyond what your doctor would normally prescribe. The study is focused on observation and understanding. You will have several appointments: one at the very beginning, a second after three months, and a final one after a year and a half.

During these appointments, the research team will perform various assessments. These include standard blood tests and filling out questionnaires about your general well-being, mental health, and any problems with your circulation. You might also do attention tests, and have your heart rate and blood pressure checked when you lie down and stand up (called a tilt table or standing test). They will also look at how your body sweats and check the function and density of small nerve fibres in your skin using special tests. Most of these initial tests will happen as part of your regular clinic visit.

Potential risks and benefits

Participating in this study won't involve new medical treatments, so there aren't direct risks from interventions. The main risks would be minor discomfort from blood draws or the various tests, which are generally routine. A potential benefit is contributing valuable information that could help others with similar conditions in the future, as well as gaining a deeper understanding of your own health. You are always free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

University clinic RWTH Aachen
Verified postcode
Aachen, Germany· Recruiting

Common questions

What is autonomic neuropathy?

It's a condition where the nerves that control automatic body functions, like heart rate, digestion, and sweating, don't work properly.

What is Ehlers-Danlos Syndrome?

It's a group of inherited conditions that affect connective tissues, often leading to very flexible joints and stretchy skin. The study focuses on the hypermobility type.

Will I get any special treatment in this study?

No, this study doesn't involve any new treatments or medications. You'll continue with your standard care.

How many times will I need to visit the clinic?

You'll have three visits: one at the start, one after 3 months, and a final one after 18 months (1.5 years).

Who are 'healthy controls'?

These are volunteers who don't have the conditions being studied. They help researchers compare results and understand what's normal.

How to find out more

Andrea Maier, physician

ans-ambulanz@ukaachen.de +492418089600 Official trial record

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