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
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
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
NCT ID
NCT03870295
First Posted
March 8, 2019
Last Updated
October 12, 2022
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
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
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PubMed Identifier
7420119
Citation
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7420120
Citation
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Citation
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Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies
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