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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT03639909
Collaborator
(none)
450
24

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Analysis of the Sweat Response According to the Pathology in Neurologic
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. Sweating autonomic test [baseline]

      Evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction to differentiate MSA-P from PD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with MSA-P or PD
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Toulouse

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Toulouse
    ClinicalTrials.gov Identifier:
    NCT03639909
    Other Study ID Numbers:
    • RC31/15/7550
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Toulouse
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 21, 2018