Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
NCT ID: NCT04310644
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-09-15
2029-09-15
Brief Summary
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Detailed Description
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Planned examinations are laboratory tests, questionnaires on mental and physical health status and circulatory disorders, attention tests, tilt table testing, standing test, sweat function, investigation of small fiber function via quantitative sensory testing as well as the density of nerve fibers in the skin. Measurements are performed at baseline mostly in clinical routine and follow up visits are offered.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Postural Orthostatic Tachycardia Syndrome
Patients with orthostatic intolerance because of Postural orthostatic tachycardia syndrome diagnosed in our outpatient clinic by tilt table examination.
No intervention planned, but all patients get our standart treatment
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Ehlers Danlos Syndrome
Patients with hypermobile or classical EDS who are already diagnosed including genetical testing for classical or vascular EDS and Marfan Syndromes
No intervention planned, but all patients get our standart treatment
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Autoimmune autonomic neuropathy/Pure autonomic failure
Patients who have an autoimmune autonomic neuropathy based on clinical diagnosis and antibody testing in our outpatient clinic. Cardial MIBG Scintigraphy should have been performed.
No intervention planned, but all patients get our standart treatment
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Healthy controls
Healthy controls with no documented cardiovascular or neurological disorders and no symtoms of autonomic failure/dizziness/fainting
No interventions assigned to this group
others
Patients who have comorbidities as mast cell activation syndrome, chronic fatigue and/or Post COVID syndrome, based on clinical diagnosis in our outpatient clinic.
No interventions assigned to this group
Interventions
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No intervention planned, but all patients get our standart treatment
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Eligibility Criteria
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Inclusion Criteria
* 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
* Pacemaker or Deep brain Stimulation
* sensory or motor Polyneuropathy
* neurodegenerative disease
18 Years
80 Years
ALL
No
Sponsors
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DLR German Aerospace Center
OTHER
RWTH Aachen University
OTHER
Responsible Party
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Andrea Maier
Primary Investigator and attending physician
Principal Investigators
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Andrea Maier
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Aachen
Locations
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University clinic RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Igharo D, Thiel JC, Rolke R, Akkaya M, Weis J, Katona I, Schulz JB, Maier A. Skin biopsy reveals generalized small fibre neuropathy in hypermobile Ehlers-Danlos syndromes. Eur J Neurol. 2023 Mar;30(3):719-728. doi: 10.1111/ene.15649. Epub 2022 Dec 13.
Gerlach DA, Maier A, Manuel J, Bach A, Hoff A, Honemann JN, Heusser K, Voit D, Frahm J, Jordan J, Tank J. Real-Time Magnetic Resonance Imaging to Study Orthostatic Intolerance Mechanisms in Human Beings: Proof of Concept. J Am Heart Assoc. 2022 Nov;11(21):e026437. doi: 10.1161/JAHA.122.026437. Epub 2022 Oct 27.
Related Links
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official homepage of our outpatient clinic for autonomic nervous system disorders
Paper Skin biopsy reveals generalized small fibre neuropathy in hypermobile Ehlers-Danlos syndromes
Other Identifiers
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19-016
Identifier Type: -
Identifier Source: org_study_id
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