New diagnostic tests in autonomic failure to improve diagnosis for PAF and MSA patients.

New diagnostic tests in autonomic failure to improve diagnosis for PAF and MSA patients. - New diagnostic tests in autonomic failure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43607

Enrollment

Registered

2016-06-08

Start date

2016-07-04

Completion date

Unknown

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic failure dysfunction of the autonomic nerve system

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
- CCM : Difference in nerve fiber density in the cornea between patients with PAF, patients with MSA and controls. A difference of 14.2 fibers / mm2 between groups is regarded as a minimal clinically relevant difference . - OCT: Difference in the RNFL (Retinal Nerve Fiber Layer) thickness between patients with PAF, patients with MSA and controls. - WISW : Difference in the degree of wrinkling of the skin in the fingertips between patients with PAF, patients with MSA and controls. A difference of 1 ' grade ' between goups is considered a minimal clinically relevant difference . - Sudoscan: Difference in electrochemical skin conductance in microsiemens (µS) between patients with PAF, patients with MSA and controls. A difference in skin conductance of 10 µS between groups is considered the minimal clinically relevant difference.	—

Measure

Time frame

- CCM : Difference in nerve fiber density in the cornea between patients with PAF, patients with MSA and controls. A difference of 14.2 fibers / mm2 between groups is regarded as a minimal clinically relevant difference . - OCT: Difference in the RNFL (Retinal Nerve Fiber Layer) thickness between patients with PAF, patients with MSA and controls. - WISW : Difference in the degree of wrinkling of the skin in the fingertips between patients with PAF, patients with MSA and controls. A difference of 1 ' grade ' between goups is considered a minimal clinically relevant difference . - Sudoscan: Difference in electrochemical skin conductance in microsiemens (µS) between patients with PAF, patients with MSA and controls. A difference in skin conductance of 10 µS between groups is considered the minimal clinically relevant difference.

—

Secondary

Measure	Time frame
ROX: difference in the arterial and venous oxygenation during a fall in blood pressure among patients with PAF, patients with MSA and controls.	—

Countries

Netherlands

Outcome results