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

Primary Purpose

Peripheral Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sympathetic skin response (SSR) measure
Sponsored by
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Nervous System Diseases focused on measuring Type C nerve fibres, Conduction velocity, Polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre hospitalier intercommunal de Toulon La Seyne sur Mer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients suffering from polyneuropathies

Control patients

Arm Description

Type C fibre conduction velocity determination in patients suffering from polyneuropathy

Type C fibre conduction velocity determination in control patients

Outcomes

Primary Outcome Measures

Measurement of sudomotor fibre conduction velocity
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
Correlation between DN4 questionnaire score and conduction velocity

Full Information

First Posted
March 8, 2019
Last Updated
October 12, 2022
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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1. Study Identification

Unique Protocol Identification Number
NCT03870295
Brief Title
Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies
Acronym
FIBREC
Official Title
Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 29, 2020 (Actual)
Study Completion Date
September 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Nervous System Diseases
Keywords
Type C nerve fibres, Conduction velocity, Polyneuropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients suffering from polyneuropathies
Arm Type
Experimental
Arm Description
Type C fibre conduction velocity determination in patients suffering from polyneuropathy
Arm Title
Control patients
Arm Type
Active Comparator
Arm Description
Type C fibre conduction velocity determination in control patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Sympathetic skin response (SSR) measure
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of sudomotor fibre conduction velocity
Description
Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Link between neuropathic pain and conduction velocity
Description
Correlation between DN4 questionnaire score and conduction velocity
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Grapperon, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Official's Role
Study Director
Facility Information:
Facility Name
Centre hospitalier intercommunal de Toulon La Seyne sur Mer
City
Toulon
ZIP/Postal Code
83200
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
7650529
Citation
Arunodaya GR, Taly AB, Swamy HS. Sympathetic skin response in acute sensory ataxic neuropathy. J Neurol Sci. 1995 May;130(1):35-8. doi: 10.1016/0022-510x(94)00271-o.
Results Reference
background
PubMed Identifier
12955550
Citation
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. doi: 10.1007/s10286-003-0107-5.
Results Reference
background
PubMed Identifier
7420119
Citation
Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in normal man. J Neurol Sci. 1980 Sep;47(3):433-48. doi: 10.1016/0022-510x(80)90098-2.
Results Reference
background
PubMed Identifier
7420120
Citation
Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in patients with polyneuropathy. J Neurol Sci. 1980 Sep;47(3):449-61. doi: 10.1016/0022-510x(80)90099-4.
Results Reference
background
PubMed Identifier
8440291
Citation
Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.
Results Reference
background
PubMed Identifier
2825012
Citation
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. doi: 10.1002/mus.880100806.
Results Reference
background
PubMed Identifier
1649263
Citation
Valls-Sole J, Monforte R, Estruch R. Abnormal sympathetic skin response in alcoholic subjects. J Neurol Sci. 1991 Apr;102(2):233-7. doi: 10.1016/0022-510x(91)90074-h.
Results Reference
background
PubMed Identifier
8913196
Citation
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.
Results Reference
background
PubMed Identifier
16995255
Citation
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. doi: 10.1113/jphysiol.1941.sp003905. No abstract available.
Results Reference
background
PubMed Identifier
5880965
Citation
Sourek K. [Reflex skin potential reactions in cases of surgically tested discopathies]. Acta Univ Carol Med (Praha). 1965:Suppl 21:99+. No abstract available. Multiple languages.
Results Reference
background
PubMed Identifier
2850351
Citation
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. doi: 10.1016/0022-510x(88)90254-7.
Results Reference
background
PubMed Identifier
3981220
Citation
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. doi: 10.1016/0022-510x(85)90120-0.
Results Reference
background
PubMed Identifier
1697257
Citation
Elie B, Guiheneuc P. Sympathetic skin response: normal results in different experimental conditions. Electroencephalogr Clin Neurophysiol. 1990 Sep;76(3):258-67. doi: 10.1016/0013-4694(90)90020-k.
Results Reference
background
PubMed Identifier
18723054
Citation
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.
Results Reference
background

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

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