Analysis of the Sweat Response According to the Pathology in Neurologic Patients (Sudoscan)

Analysis of the Sweat Response According to the Pathology in Neurologic

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

Study Overview

• Status: Completed
• Conditions: Neurological Disorder
• Intervention / Treatment: Procedure: sweating function; Procedure: Cardiovascular function

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 450

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the autonomic laboratory of the neurology department at Toulouse University Hospital

Description

Inclusion Criteria:

• Patients with MSA-P or PD

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MSA-P; Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function	Procedure: sweating function; Sweating dysfunction by Sudoscan; Other Names: sweating dysfunction by Sudoscan; Procedure: Cardiovascular function; Cardiovascular (CV) tests
PD patients; Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function	Procedure: sweating function; Sweating dysfunction by Sudoscan; Other Names: sweating dysfunction by Sudoscan; Procedure: Cardiovascular function; Cardiovascular (CV) tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweating autonomic test	Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Anne Pavy-Le Traon, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: sweat gland
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: RC31/15/7550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No