NCT04310644 Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
| NCT ID | NCT04310644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RWTH Aachen University |
| Condition | Autonomic Neuropathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-09-15 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-09-15 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Andrea Maier
PRINCIPAL INVESTIGATOR
University Hospital, Aachen
Frequently Asked Questions
Who can join the NCT04310644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Autonomic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04310644 currently recruiting?
Yes, NCT04310644 is actively recruiting participants. Contact the research team at ans-ambulanz@ukaachen.de for enrollment information.
Where is the NCT04310644 trial being conducted?
This trial is being conducted at Aachen, Germany.
Who is sponsoring the NCT04310644 clinical trial?
NCT04310644 is sponsored by RWTH Aachen University. The principal investigator is Andrea Maier at University Hospital, Aachen. The trial plans to enroll 200 participants.