Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies (FIBREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03870295

Recruitment Status : Completed

First Posted : March 12, 2019

Last Update Posted : August 30, 2021

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Description

Brief Summary:

Peripheral nerve diseases can separately affect different kind of nerve fibres. Globally two kinds of fibres can be distinguished: large size and small size. The usual electromyogram only investigates large size fibres. Techniques to explore small size fibre function exist but are not used in common practice because of their very specialized aspect or their lack of diagnostic value. The purpose of this study is to develop a measurement technique of small size type C nerve fibre conduction velocity, to show that this velocity is reduced in patients suffering from polyneuropathies and to establish reference values in healthy patients.

Condition or disease	Intervention/treatment	Phase
Peripheral Nervous System Diseases	Diagnostic Test: Sympathetic skin response (SSR) measure	Not Applicable

Detailed Description:

Sympathetic skin response (SSR) is one of the simplest means to register the electrophysiological activity of small size nerve fibres. It corresponds to the emission of an electrical potential by sweat glands due to stimulation by type C nerve fibres. These fibres belong to vegetative and somatic nervous systems which can be activated by various stimuli.

Medical applications were considered in the context of polyneuropathies with dysautonomia but SSR did not yield a satisfactory diagnostic value. Parameters used were SSR latency and amplitude. Latency showed little variation with pathology and it is considered that as long as fibres are present their conduction velocity is respected as an all-or-nothing phenomenon. On the contrary, amplitude is very variable, in particular between subjects, which prevents from applying a confidence interval to a given subject. Only unilateral suppression of the response seems to be a reliable criterion and gave results in the context of peripheral nervous pathologies.

The good results obtained with "response suppression" shows SSR sensibility. The discredit of "conduction velocity" variable seems to come from a publication using microneurography. However with this technique only one fascicle is investigated and preferably one giving a good signal, so not representative of all nerve fibres.

Consistent results were achieved with a technique consisting in recording SSR at two points of a same path, separated by a known distance. Knowing the difference of response latency at these two points, velocity could be deduced on the path. This technique was tested in healthy patients in 1988 taking as measurement sites the hand stuck on the body and the ground as a reference for foot plantar. It gave a velocity equivalent to the result found by another team with the same method. The purpose of the study is to apply this technique to pathology.

It should be noted that the velocity measured in this way depends on superior and inferior limb paths, on a medullar portion between C7 et D12 and on pre-ganglionic neurone portion. It has consequently no lesion focalisation capacities and is more appropriate for polyneuropathies with diffuse damage. Nevertheless, it has two advantages. First sweet follicles are in the same functional state in hand and on foot since stimulation intervals are the same at both levels. Secondly the influence of cerebral trunk centres on SSR emission and latency may be bypassed. Thus the study hypothesis is that conduction velocity determination of SSR constituting fibres will better characterize their functional state than response latency measurement which is subject to central excitability variations.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
Actual Study Start Date :	September 30, 2019
Actual Primary Completion Date :	September 29, 2020
Actual Study Completion Date :	September 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber Neurologic Diseases Peripheral Nerve Disorders

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Patients suffering from polyneuropathies Type C fibre conduction velocity determination in patients suffering from polyneuropathy	Diagnostic Test: Sympathetic skin response (SSR) measure Ankle - ground distance measurement, hand and foot cutaneous temperature reading, low intensity electrical stimulations on hand and on foot to determine SSR at these two points and DN4 questionnaire to assess the possible presence of neuropathic pain
Active Comparator: Control patients Type C fibre conduction velocity determination in control patients	Diagnostic Test: Sympathetic skin response (SSR) measure Ankle - ground distance measurement, hand and foot cutaneous temperature reading, low intensity electrical stimulations on hand and on foot to determine SSR at these two points and DN4 questionnaire to assess the possible presence of neuropathic pain

Outcome Measures

Primary Outcome Measures :

Measurement of sudomotor fibre conduction velocity [ Time Frame: 30 minutes ]
Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients

Secondary Outcome Measures :

Link between neuropathic pain and conduction velocity [ Time Frame: 30 minutes ]
Correlation between DN4 questionnaire score and conduction velocity

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria for experimental group:

Patients with polyneuropathy explicit suspicion or whose symptomatology evokes this disease confirmed by electromyogram
Free informed consent of patient

Inclusion Criteria for control group:

Patients having a consultation scheduled in neurology department
Free informed consent of patient

Exclusion Criteria for experimental group:

Age < 18 years old
Signs or medical history of central nervous system damage
Person suffering from another peripheral nervous system pathology than polyneuropathy
Known or suspected pregnancy and breastfeeding women
Patients not covered by a social security regimen
Patients under legal guardianship
Patients deprived of their liberty due to judicial or administrative decision

Exclusion Criteria for control group:

Age < 18 years old
Polyneuropathy suspicion
Signs or medical history of peripheral or central nervous system damage
Known or suspected pregnancy and breastfeeding women
Patients not covered by a social security regimen
Patients under legal guardianship
Patients deprived of their liberty due to judicial or administrative decision

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870295

Locations

Layout table for location information

France
Centre hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, France, 83200

Sponsors and Collaborators

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

Layout table for investigator information

Study Director:	Jacques Grapperon, MD	Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

More Information

Publications:

Arunodaya GR, Taly AB, Swamy HS. Sympathetic skin response in acute sensory ataxic neuropathy. J Neurol Sci. 1995 May;130(1):35-8.

Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. Review.

Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in normal man. J Neurol Sci. 1980 Sep;47(3):433-48.

Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in patients with polyneuropathy. J Neurol Sci. 1980 Sep;47(3):449-61.

Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8.

Soliven B, Maselli R, Jaspan J, Green A, Graziano H, Petersen M, Spire JP. Sympathetic skin response in diabetic neuropathy. Muscle Nerve. 1987 Oct;10(8):711-6.

Valls-Sole J, Monforte R, Estruch R. Abnormal sympathetic skin response in alcoholic subjects. J Neurol Sci. 1991 Apr;102(2):233-7.

Montagna P, Marchello L, Plasmati R, Ferlini A, Patrosso MC, Salvi F. Electromyographic findings in transthyretin (TTR)-related familial amyloid polyneuropathy (FAP). Electroencephalogr Clin Neurophysiol. 1996 Oct;101(5):423-30.

Carmichael EA, Honeyman WM, Kolb LC, Stewart WK. Peripheral conduction rate in the sympathetic nervous system of man. J Physiol. 1941 Mar 25;99(3):338-43.

Sourek K. [Reflex skin potential reactions in cases of surgically tested discopathies]. Acta Univ Carol Med (Praha). 1965:Suppl 21:99+. Multiple languages.

Uncini A, Pullman SL, Lovelace RE, Gambi D. The sympathetic skin response: normal values, elucidation of afferent components and application limits. J Neurol Sci. 1988 Nov;87(2-3):299-306.

Knezevic W, Bajada S. Peripheral autonomic surface potential. A quantitative technique for recording sympathetic conduction in man. J Neurol Sci. 1985 Feb;67(2):239-51.

Elie B, Guiheneuc P. Sympathetic skin response: normal results in different experimental conditions. Electroencephalogr Clin Neurophysiol. 1990 Sep;76(3):258-67.

Sequeira H, Hot P, Silvert L, Delplanque S. Electrical autonomic correlates of emotion. Int J Psychophysiol. 2009 Jan;71(1):50-6. doi: 10.1016/j.ijpsycho.2008.07.009. Epub 2008 Jul 23. Review.

Layout table for additonal information

Responsible Party:	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier:	NCT03870295
Other Study ID Numbers:	2018-CHITS-03 2018-A02621-54 ( Other Identifier: Id-RCB )
First Posted:	March 12, 2019 Key Record Dates
Last Update Posted:	August 30, 2021
Last Verified:	August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:


Type C nerve fibres Conduction velocity Polyneuropathy

Additional relevant MeSH terms:

Layout table for MeSH terms

Nervous System Diseases Polyneuropathies Peripheral Nervous System Diseases Neuromuscular Diseases

To Top