Peripheral Nervous System DiseasesFIBRECNCT03870295
Technique to Measure Type C Fibre Nerve Conduction Velocitynerve Fibers in Polyneuropathies
A study testing Sympathetic skin response (SSR) measure in people with Peripheral Nervous System Diseases, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nervous System Diseases
- What is being tested?
- Sympathetic skin response (SSR) measure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2019to 29 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, 83200
About this study
Official title: Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
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.
Read the 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.
- Conditions
- Peripheral Nervous System Diseases
- Being tested
- Sympathetic skin response (SSR) measure
- Keywords
- Type C nerve fibres, Conduction velocity, Polyneuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathetic skin response (SSR) measureDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients suffering from polyneuropathies | Experimental | Type C fibre conduction velocity determination in patients suffering from polyneuropathy Receives: Diagnostic Test: Sympathetic skin response (SSR) measure |
| Control patients | Active comparator | Type C fibre conduction velocity determination in control patients Receives: Diagnostic Test: Sympathetic skin response (SSR) measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of sudomotor fibre conduction velocity
Sudomotor fibre conduction velocity measurement and comparison between patients suffering from polyneuropathy and control patients
Measured: 30 minutes
Secondary outcomes (1)
Link between neuropathic pain and conduction velocity
Correlation between DN4 questionnaire score and conduction velocity
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start30 Sep 2019
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Peripheral Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Grapperon, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870295
- Sponsor's protocol ID
- 2018-CHITS-03
- Other IDs
- 2018-A02621-54
- Acronym
- FIBREC
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7650529Vetrugno 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.
PubMed 12955550Fagius 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.
PubMed 7420119Fagius 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.
PubMed 7420120Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.
PubMed 8440291Soliven 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.
PubMed 2825012Valls-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.
PubMed 1649263Montagna 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.
PubMed 8913196Carmichael 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.
PubMed 16995255Sourek 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.
PubMed 5880965Uncini 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.
PubMed 2850351Knezevic 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.
PubMed 3981220Elie 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.
PubMed 1697257Sequeira 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.
PubMed 18723054
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.
- ClinicalTrials.gov ID
- NCT03870295
- Acronym / sponsor ID
- FIBREC / 2018-CHITS-03
- Conditions
- Peripheral Nervous System Diseases
- Keywords
- Type C nerve fibres, Conduction velocity, Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients suffering from polyneuropathies | Experimental | Diagnostic Test: Sympathetic skin response (SSR) measureType C fibre conduction velocity determination in patients suffering from polyneuropathy |
| Control patients | Active comparator | Diagnostic Test: Sympathetic skin response (SSR) measureType C fibre conduction velocity determination in control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sympathetic skin response (SSR) measureAnkle - 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 | Diagnostic test | Control patients, Patients suffering from polyneuropathies |
Primary outcome
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
1 secondary outcome
Link between neuropathic pain and conduction velocity
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 7650529Arunodaya 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.
- Background: PubMed 12955550Vetrugno 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.
- Background: PubMed 7420119Fagius 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.
- Background: PubMed 7420120Fagius 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.
- Background: PubMed 8440291Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.
- Background: PubMed 2825012Soliven 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.
- Background: PubMed 1649263Valls-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.
- Background: PubMed 8913196Montagna 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.
- Background: PubMed 16995255Carmichael 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.
- Background: PubMed 5880965Sourek 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.
- Background: PubMed 2850351Uncini 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.
- Background: PubMed 3981220Knezevic 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.
- Individual participant dataSharing planned: No
Related trials for Peripheral Nervous System Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Grapperon, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sympathetic skin response (SSR) measure in people with Peripheral Nervous System Diseases, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of sudomotor fibre conduction velocity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03870295, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.