Analysis of the Sweat Response According to the Pathology in Neurologic Patients

Neurological Disorder Clinical Trial

— Sudoscan  

Official title:

Analysis of the Sweat Response According to the Pathology in Neurologic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03639909
• Other study ID #: RC31/15/7550
• Status: Completed
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes.

CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing).

First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test

Description:

Sweat glands are innervated by thin and un myelinated sympathetic C-fibers that can be impaired in neuropathies,especially length-dependent ones. Sweating dysfunction has been shown in several neurological peripheral disorders and it has been suggested that sweating function should be included among the diagnostic tests for the early detection of autonomic neuropathies. Several methods have been developed, but the lack of easy and quick tests to diagnose sweating dysfunction has restricted widespread use in clinical practice. Measurement of electrochemical skin conductance (ESC) using Sudoscan® is a new method for quick, non-invasive and quantitative assessment of sweating. This technique has demonstrated its usefulness in detecting autonomic and small fiber neuropathy, especially in diabetic patients.The aim of this study was to evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction by Sudoscan®, alone or in combination, to differentiate MSA-P from PD. Among the CV tests, the present study particularly looked at those tests already recommended as screening bedside tests in diabetic patients (HR variations with deep breathing and BP variations during stand test) ; these tests are rapid and easy to perform. HR variations with deep breathing depend on parasympathetic tone and BP variations depend on vasomotor sympathetic response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with MSA-P or PD

Exclusion Criteria:

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorder

Intervention

Procedure:
• sweating function
Sweating dysfunction by Sudoscan
• Cardiovascular function
Cardiovascular (CV) tests

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sweating autonomic test	Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD	baseline