- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870295
Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies (FIBREC)
Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulon, France, 83200
- Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients suffering from polyneuropathies
Type C fibre conduction velocity determination in patients suffering from polyneuropathy
|
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
|
Active Comparator: Control patients
Type C fibre conduction velocity determination in control patients
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of sudomotor fibre conduction velocity
Time Frame: 30 minutes
|
Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Link between neuropathic pain and conduction velocity
Time Frame: 30 minutes
|
Correlation between DN4 questionnaire score and conduction velocity
|
30 minutes
|
Collaborators and Investigators
Investigators
- Study Director: Jacques Grapperon, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-CHITS-03
- 2018-A02621-54 (Other Identifier: Id-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Nervous System Diseases
-
University of Milano BicoccaRecruitingPeripheral NeuropathiesItaly
-
Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruiting
-
Bioness IncRecruitingNervous System Diseases | Chronic Pain | Peripheral Nervous System Diseases | Peripheral Neuropathy | Peripheral Nerve Injuries | Peripheral Nervous System Problem | Peripheral NervousUnited States
-
M.D. Anderson Cancer CenterFoundation for Anesthesia Education and ResearchRecruitingNeuropathy;PeripheralUnited States
-
The University of Texas Health Science Center at...Active, not recruitingPeripheral NeuropathiesUnited States
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Arash Asher, MDVoxxLifeRecruitingNeuropathy | Chemotherapy-induced Peripheral Neuropathy | Neuropathy;PeripheralUnited States
-
Major Extremity Trauma Research ConsortiumActive, not recruitingPeripheral Nerve Injury(Ies)United States
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.UnknownDiabetic Peripheral Neuropathy
-
Hawler Medical UniversityUnknownDiabetic Peripheral NeuropathyIraq
Clinical Trials on Sympathetic skin response (SSR) measure
-
Cairo UniversityCompleted
-
AdventHealthCompletedPain | Pancreatic CancerUnited States
-
Marmara UniversityRecruitingFamilial Mediterranean Fever | Autonomic DysfunctionTurkey
-
Adiyaman UniversityRecruiting
-
Abant Izzet Baysal UniversityCompleted
-
Emory UniversityWithdrawn
-
Laboratorios Leti, S.L.Completed
-
Life UniversitySuspended
-
Hospital for Special Surgery, New YorkOslo University HospitalCompletedNerve; Disorder, Sympathetic
-
Rutgers, The State University of New JerseyTerminated