Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}], 'ancestors': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2019-03-08', 'studyFirstSubmitQcDate': '2019-03-11', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of sudomotor fibre conduction velocity', 'timeFrame': '30 minutes', 'description': 'Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients'}], 'secondaryOutcomes': [{'measure': 'Link between neuropathic pain and conduction velocity', 'timeFrame': '30 minutes', 'description': 'Correlation between DN4 questionnaire score and conduction velocity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type C nerve fibres', 'Conduction velocity', 'Polyneuropathy'], 'conditions': ['Peripheral Nervous System Diseases']}, 'referencesModule': {'references': [{'pmid': '7650529', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12955550', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7420119', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7420120', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8440291', 'type': 'BACKGROUND', 'citation': 'Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.'}, {'pmid': '2825012', 'type': 'BACKGROUND', 'citation': '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': '1649263', 'type': 'BACKGROUND', 'citation': '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': '8913196', 'type': 'BACKGROUND', 'citation': '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': '16995255', 'type': 'BACKGROUND', 'citation': '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': '5880965', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2850351', 'type': 'BACKGROUND', 'citation': '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': '3981220', 'type': 'BACKGROUND', 'citation': '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': '1697257', 'type': 'BACKGROUND', 'citation': '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': '18723054', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMedical 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.\n\nThe 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.\n\nConsistent 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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for experimental group:\n\n* Patients with polyneuropathy explicit suspicion or whose symptomatology evokes this disease confirmed by electromyogram\n* Free informed consent of patient\n\nInclusion Criteria for control group:\n\n* Patients having a consultation scheduled in neurology department\n* Free informed consent of patient\n\nExclusion Criteria for experimental group:\n\n* Age \\< 18 years old\n* Signs or medical history of central nervous system damage\n* Person suffering from another peripheral nervous system pathology than polyneuropathy\n* Known or suspected pregnancy and breastfeeding women\n* Patients not covered by a social security regimen\n* Patients under legal guardianship\n* Patients deprived of their liberty due to judicial or administrative decision\n\nExclusion Criteria for control group:\n\n* Age \\< 18 years old\n* Polyneuropathy suspicion\n* Signs or medical history of peripheral or central nervous system damage\n* Known or suspected pregnancy and breastfeeding women\n* Patients not covered by a social security regimen\n* Patients under legal guardianship\n* Patients deprived of their liberty due to judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT03870295', 'acronym': 'FIBREC', 'briefTitle': 'Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer'}, 'officialTitle': 'Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.', 'orgStudyIdInfo': {'id': '2018-CHITS-03'}, 'secondaryIdInfos': [{'id': '2018-A02621-54', 'type': 'OTHER', 'domain': 'Id-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients suffering from polyneuropathies', 'description': 'Type C fibre conduction velocity determination in patients suffering from polyneuropathy', 'interventionNames': ['Diagnostic Test: Sympathetic skin response (SSR) measure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control patients', 'description': 'Type C fibre conduction velocity determination in control patients', 'interventionNames': ['Diagnostic Test: Sympathetic skin response (SSR) measure']}], 'interventions': [{'name': 'Sympathetic skin response (SSR) measure', 'type': 'DIAGNOSTIC_TEST', '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', 'armGroupLabels': ['Control patients', 'Patients suffering from polyneuropathies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83200', 'city': 'Toulon', 'country': 'France', 'facility': 'Centre hospitalier intercommunal de Toulon La Seyne sur Mer', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'overallOfficials': [{'name': 'Jacques Grapperon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Intercommunal Toulon La Seyne sur Mer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}