ew diagnostic tests in autonomic failure to improve diagnosis for PAF and MSA patients.
- Conditions
- Autonomic failuredysfunction of the autonomic nerve system1004226110034606
- Registration Number
- NL-OMON43607
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 33
All participants: older than 18 years and the ability to provide informed consent.
Patients with PAF are defined according to the consensus of the American Autonomic Society and the American Acedemy of Neurology (AAN):
- Presence of NOH AND
- Evidence of more widespread autonomic failure AND
- No other neurological features
Patients with MSA are defined according to the second consensus criteria of the AAN.
Healty controls: no signs of autonomic failure or other relevant neurological or other disorders.
For all participants: younger than 18 years or not able to provide informed consent.
Furthermore, a potential subject who meets any of the following criteria will be excluded from participation in this study:
- Diabetes Mellitus
- Inability to sustain the investigations due to the nature of their disease
- Ophtalmological morbidity: AMD, macular dystrophies, glaucoma, herpes keratitis, history of cornea surgery like refractive surgery
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- CCM : Difference in nerve fiber density in the cornea between patients with<br /><br>PAF, patients with MSA and controls. A difference of 14.2 fibers / mm2 between<br /><br>groups is regarded as a minimal clinically relevant difference .<br /><br>- OCT: Difference in the RNFL (Retinal Nerve Fiber Layer) thickness between<br /><br>patients with PAF, patients with MSA and controls.<br /><br>- WISW : Difference in the degree of wrinkling of the skin in the fingertips<br /><br>between patients with PAF, patients with MSA and controls. A difference of 1 '<br /><br>grade ' between goups is considered a minimal clinically relevant difference .<br /><br>- Sudoscan: Difference in electrochemical skin conductance in microsiemens (µS)<br /><br>between patients with PAF, patients with MSA and controls. A difference in skin<br /><br>conductance of 10 µS between groups is considered the minimal clinically<br /><br>relevant difference.</p><br>
- Secondary Outcome Measures
Name Time Method <p>ROX: difference in the arterial and venous oxygenation during a fall in blood<br /><br>pressure among patients with PAF, patients with MSA and controls.</p><br>