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

NCT03870295 | Completed

• 2 other identifiers: 2018-CHITS-032018-A02621-54
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nervous System Diseases

Keywords

Type C nerve fibres; Conduction velocity; Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• Measurement of sudomotor fibre conduction velocity

  Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients

  30 minutes

Secondary Outcomes (1)

• Link between neuropathic pain and conduction velocity

  30 minutes

Study Arms (2)

Patients suffering from polyneuropathies

EXPERIMENTAL

Type C fibre conduction velocity determination in patients suffering from polyneuropathy

Diagnostic Test: Sympathetic skin response (SSR) measure

Control patients

ACTIVE COMPARATOR

Type C fibre conduction velocity determination in control patients

Diagnostic Test: Sympathetic skin response (SSR) measure

Interventions

Sympathetic skin response (SSR) measure DIAGNOSTIC_TEST

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

Control patients; Patients suffering from polyneuropathies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with polyneuropathy explicit suspicion or whose symptomatology evokes this disease confirmed by electromyogram
• Free informed consent of patient
• Patients having a consultation scheduled in neurology department
• Free informed consent of patient

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre hospitalier intercommunal de Toulon La Seyne sur Mer

Toulon, 83200, France

Location

Related Publications (14)

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  PMID: 7650529 BACKGROUND

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  PMID: 12955550 BACKGROUND

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  PMID: 7420119 BACKGROUND

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  PMID: 7420120 BACKGROUND

• Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.

  PMID: 8440291 BACKGROUND

• 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.

  PMID: 2825012 BACKGROUND

• 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.

  PMID: 1649263 BACKGROUND

• 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.

  PMID: 8913196 BACKGROUND

• 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.

  PMID: 16995255 BACKGROUND

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  PMID: 5880965 BACKGROUND

• 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.

  PMID: 2850351 BACKGROUND

• 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.

  PMID: 3981220 BACKGROUND

• 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.

  PMID: 1697257 BACKGROUND

• 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.

  PMID: 18723054 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Polyneuropathies

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Jacques Grapperon, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 12, 2019
• Study Start: September 30, 2019
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)