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

NCT ID: NCT03639909

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Neurological Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

MSA-P

Patients with multiple systeme atrophy (MSA) with predominant parkinsonism (MSA-P) had evaluation of cardiovascular function and sweating function

sweating function

Intervention Type: PROCEDURE

Sweating dysfunction by Sudoscan

Cardiovascular function

Intervention Type: PROCEDURE

Cardiovascular (CV) tests

PD patients

Parkinson's disease (PD) patients had evaluation of cardiovascular function and sweating function

sweating function

Intervention Type: PROCEDURE

Sweating dysfunction by Sudoscan

Cardiovascular function

Intervention Type: PROCEDURE

Cardiovascular (CV) tests

Interventions

sweating function

Sweating dysfunction by Sudoscan

Intervention Type: PROCEDURE

Cardiovascular function

Cardiovascular (CV) tests

Intervention Type: PROCEDURE

Other Intervention Names

sweating dysfunction by Sudoscan

Eligibility Criteria

Inclusion Criteria

• Patients with MSA-P or PD

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Pavy-Le Traon, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Other Identifiers

RC31/15/7550

Identifier Type: -

Identifier Source: org_study_id