Clinical trial NCT03870295: Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies
Official title: Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nervous System Diseases
Keywords: Type C nerve fibres
Conduction velocity
Polyneuropathy
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Measurement of sudomotor fibre conduction velocity
timeFrame: 30 minutes
Secondary outcomes:
measure: Link between neuropathic pain and conduction velocity
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Jacques Grapperon, MD
role: STUDY_DIRECTOR
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