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NCT Number: NCT04310644

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

We examine patients with different autonomic neuropathies and Ehlers Danlos syndromes compared to healthy controls at three different points over time (baseline, after 3 months and after 1.5 years) to gain knowledge about the course of this disease and understand its pathophysiology, with a focus on Small Fiber neuropathy. Moreover we will validate the german version of the Malmö POTS Score and establish an easy diagnostic scheme for patients in outpatient care.

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Key information

Conditions

Autonomic Neuropathy Autonomic Nervous System Diseases Ehlers-Danlos Syndrome Hypermobility Type Ehlers-Danlos syndrome type 3 Nervous System Diseases Neuromuscular Diseases Orthostatic Intolerance Peripheral Nervous System Diseases Postural Orthostatic Tachycardia Syndrome Postural Tachycardia Syndrome Primary Dysautonomias Small Fiber Neuropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Inclusion of patients with autoimmune autonomic neuropathies/ pure autonomic failure, postural orthostatic tachycardia syndrome, small fiber neuropathies, Ehlers-Danlos syndromes, Mast cell activation syndrom, Chronic fatigue syndrome and PostCOVID syndrome in our Registry study with follow up visits. Comparison to healthy controls concerning selected examinations.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention planned, but all patients get our standart treatment

Other

Patients are selected from clinical Routine and get our standart Treatment based on their disease

Primary outcomes

  1. Blood pressure

    Time frame: baseline, 3 months and 18 months

    Change in systolic and diastolic blood pressure over time

  2. Heart frequency

    Time frame: baseline, 3 months and 18 months

    Change in heart frequency over time

  3. Skin biopsy

    Time frame: baseline

    intraepithelial nerve fiber density between groups

  4. Composite autonomic severity Score

    Time frame: baseline, 3 months and 18 months

    Change of the Score over time, the results are interpreted as normal (score=0), mild (score=1-3), moderate (score=4-6) or severe (score=7-10)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Maier, physician

CONTACT

[email protected]

+492418089600 ext. +492418089600

Denver Igharo, student

CONTACT

[email protected]

+492418089600 ext. +492418089600

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • DLR German Aerospace Center

Registry information

Official study title

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)

Acronym: ProANS

Important dates

Study start
2019
Primary completion
2028
Study completion
2029
First posted
Mar 17, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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