Observing autonomic neuropathies and Ehlers Danlos syndromes over time
Autonomic Neuropathy and Its Pathophysiology in Autoimmune Autonomic Neuropathies, Postural Orthostatic Tachycardia Syndrome and Ehlers Danlos Syndromes: Peripheral Autonomic Small Fiber Neuropathy or Central Autonomic Failure? Validation of the Malmö POTS Score and a Better Diagnosis of POTS in Patientes With Autnomic Failure (VaGeMAPS-3-step-Diag)
This study is trying to understand how autonomic neuropathies and Ehlers Danlos syndromes change over time in patients compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Trial ID | NCT04310644 on ClinicalTrials.gov |
What this trial studies
This study examines patients with various autonomic neuropathies and Ehlers Danlos syndromes, comparing them to healthy controls at three different time points: baseline, after 3 months, and after 1.5 years. The goal is to gain insights into the progression of these conditions and their underlying mechanisms, particularly focusing on small fiber neuropathy. Participants will undergo a series of assessments, including laboratory tests, questionnaires, and specialized tests to evaluate their health status and nerve function. The study also aims to validate a German version of the Malmö POTS Score and create a straightforward diagnostic scheme for outpatient care.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-80 with autonomic neuropathy, postural orthostatic tachycardia syndrome, hypermobile or classical Ehlers Danlos syndromes, chronic fatigue syndrome, mast cell activation syndrome, or PostCOVID syndrome.
Not a fit: Patients with pregnancy, pacemakers, deep brain stimulation, sensory or motor polyneuropathy, or neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding and management of autonomic neuropathies and Ehlers Danlos syndromes, leading to better patient outcomes.
How similar studies have performed: While this study builds on existing knowledge, the specific combination of conditions and the proposed methodology may offer novel insights into these syndromes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * autonomic neuropathy * Postural orthostatic tachycardia syndrome * hypermobile or classical Ehlers Danlos syndromes * Chronic fatigue syndrome, mast cell activation syndrome and/or PostCOVID * healty controls * between 18-80 years * in patients: diagnosis and clinical testing in our outpatient clinic * German speaking Exclusion Criteria: * pregnancy * Pacemaker or Deep brain Stimulation * sensory or motor Polyneuropathy * neurodegenerative disease
Where this trial is running
Aachen, North Rhine-Westphalia
- University clinic RWTH Aachen — Aachen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Andrea Maier — University Hospital, Aachen
- Study coordinator: Andrea Maier, physician
- Email: ans-ambulanz@ukaachen.de
- Phone: +492418089600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.