Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-02 @ 5:22 AM
Study NCT ID:
NCT03870295
Status:
COMPLETED
Last Update Posted:
2022-10-13
First Post:
2019-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies
Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Organization:
Study Overview
Official Title:
Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBREC
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-A02621-54 | OTHER | Id-RCB | View |