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

Completed

• Conditions: Neurological Disorder
• Interventions: Procedure: sweating function; Procedure: Cardiovascular function

• Registration Number: NCT03639909
• Lead Sponsor: University Hospital, Toulouse

Brief 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

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 Timeline

• Study Start: 2015-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2018-08
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-20
• Last Update Submitted: 2018-08-20
• Study First Posted: 2018-08-21
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with MSA-P or PD

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PD patients	Cardiovascular function	Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function
PD patients	sweating function	Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function
MSA-P	sweating function	Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function
MSA-P	Cardiovascular function	Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function

Primary Outcome Measures

Name	Time	Method
Sweating autonomic test	baseline	Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD