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CompletedNCT03639909SudoscanUpdated Aug 21, 2018

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

An observational study in Neurological Disorder, sponsored by University Hospital, Toulouse. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
450
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Neurological Disorder

Keywords

  • sweat gland
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In context

Nervous System Diseases

975 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.

This study's enrollment of 450 is above the median of 127 across 318 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients with MSA-P or PD

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • MSA-P

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

    Procedure: sweating function · Procedure: Cardiovascular function

  • PD patients

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

    Procedure: sweating function · Procedure: Cardiovascular function

Interventions

  • Proceduresweating function

    Sweating dysfunction by Sudoscan

    Also known as: sweating dysfunction by Sudoscan

  • ProcedureCardiovascular function

    Cardiovascular (CV) tests

06

What researchers measure

Primary outcomes

  1. Sweating autonomic test

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

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03639909
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Aug 21, 2018
Start date
Mar 2015
Primary completion
Mar 2017
Completion
Mar 2017
Last update
Aug 21, 2018

Study contacts

Anne Pavy-Le Traon, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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