Chronic Inflammatory Demyelinating PolyradiculoneuropathyNCT04978623
Role of High Frequency Ultrasound in Demyelinating Polyneuropathies
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The use of neuroimaging in the evaluation of neuromuscular pathologies is a promising and rapidly expandinf field. Among the different imaging techniques employed, nerve ultrasound is of particular interest given it's non invasivity, lack of side effects, accesibility and low cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- What is being tested?
- high frequency ultrasound
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The patients in this study came to the Nice University Hospital in the Peripheral Nervous System and Muscle (SNPM) department for a consultation in the context of neuropathy. They were diagnosed with CIDP, MMNBC, anti-MAG and L-S and have undergone an ultrasound in addition to standard diagnosis protocol.
Who may be able to join
- Male or female,
- 18 years of age or older
- Patients with CIDP or NMMBC or definite anti-MAG neuropathy according to the criteria defined by EFNS 2010
- Signing of an informed consent.
- Affiliation or beneficiary of the social security system
Who cannot join
- Subjects with a medical condition deemed by the investigator to interfere with the proper conduct of the study.
- Positive pregnancy test.
- Pregnant or breastfeeding woman (a urine pregnancy test will be performed for women of childbearing age) A urine The results will be communicated to the patient by a doctor of her choice.
- Persons deprived of their liberty by a judicial or administrative decision;
- Persons hospitalised without consent;
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent.
- Incapacity of the subject to cooperate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Analysis of Morphological Aspects of Nerve Fibers in Demyelinationg Polyneuropathies Using HIGH FREQUENCY Ultrasound
The use of neuroimaging in the evaluation of neuromuscular pathologies is a promising and rapidly expandinf field. Among the different imaging techniques employed, nerve ultrasound is of particular interest given it's non invasivity, lack of side effects, accesibility and low cost. This exam provides complementary data to electroneuromyography (ENMG), enabeling the physician to visualise the morphological correspondents of electrophysiological abnormalities with a spatial resolution at least as good as MRI.
Chronic Inflammatory Demyelinating Polyradiculoneuritis (CIDP), Multifocal Motor Neuropathy with Conduction Blocks (MMNBC), Lewis and Sumner syndrome (L-S syndrome) and anti-MAG antibody-associated neuropathies (anti-MAG) are among the main chronic inflammatory neuropathies of autoimmune etiology. The diagnosis of these diseases is based on clinical, paraclinical and ENMG examinations. Several recent studies have highlighted the valuable role of ultrasound not only in the diagnosis but also for follow up of patients afflicted by this group of diseases.
Read more
However, the current ultrasound imaging techniques does not allow for a detailed study of the internal structure of the nerves. The developement of technologies with improved resolution contribute to further the knowledge in this innovative field and to better understand the pathophysiological mechanisms responsible for initiation and progression of inflammatory nerve disorders.In the Department of Ultrasound at the Nice University Hospital in France the team have at its disposal a high frequency untrasound that the team use to explore the peripheral nervous system.
The scientific hypothesis of this pilot study rests on the premise that demyelinationg neuropathies are a heterogenous group where different types present with different morphological characteristics not only at the level of the nerve as a whole, but also at the level of the nerve fascicles and of the peri- and intra-neural vascular structures. In this respect, high frequency ultrasound allows us to visualise different segments of affected nerves and to obtain morphological details which the team then compare with existing ultrasound data in the literature (high frequency ultrasound: 10-20 MHz). Thanks to this non-invasive and painless technique, the nerve can be rapidly visualised along its entire length in static and dynamic mode. In addition, high frequency ultrasound will give us access to complementary data on the morphology of the soft tissues and the peri- and intra-neural vascular structures which may be useful in shedding light on the underlying pathophysiologycal processes. Another important aspect is the opportunity to make electromyographic and clinical correlations The main parameter The team will study in ultrasound will be hypertrophy, corresponding to an increase in the cross-sectional area of the nerve. the team will also conduct analysis on other less codified parameters, such as epineural and endoneural vascularisation (using the Doppler mode), as well as nerve fascicles anatomy (size, organisation). Identification of different characteristics may be of diagnostic interest in cases where the clinical, paraclinical and ENMG examinations do not allow us to make a diagnostic and therapeutic decision, but it can also prove useful in the follow-up of patients and response to treatment.
This is a descriptive, pilot, mono-centric, multiparametric and retrospective analysis study on patients followed in our centre with a diagnosis of CIDP, NMMBC, L-S syndrom and anti-MAG
- Being tested
- high frequency ultrasound
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency ultrasoundOther
high frequency ultrasound in subgroups of patients with CIDP, anti-MAG, NMMBC and L-S syndrome
| Study group | Role | What they receive |
|---|---|---|
| Patient with CIDP | CIDP, is an acquired chronic inflammatory neuropathy characterised by : progressive symmetrical weakness of the proximal and to a lesser extent distal muscles of the lower and/or upper limbs, altered sensitivity and a decrease/abolition of the osteotendinous reflexes. The condition can be relapsing (30% of cases), chronically progressive (60%), or monophasically with total subsequent recovery (10%). Cranial nerve involvement is possible (5-30% of cases). Neuropathic pain as well as respiratory muscle and sub-clinical central nervous system involvement are described. Receives: Other: high frequency ultrasound | |
| Patient with MMNCB | Patients with MMNCB are at the crossroads between chronic demyelinating neuropathies and motor neuron diseases, the latter for which they constitute a differential diagnosis. The disease usually presents asymmetrically and affects the upper limbs more frequently. The course of the disease is unpredictable, and may be limited to one or two motor nerves or progress to other motor nerves in the contralateral upper limb and possibly the lower limbs. In all cases, the motor deficit is asymmetrical, multi-truncular in distribution, and is usually accompanied by cramps and fasciculations, and eventually by amyotrophy. Osteotendinous reflexes are usually diminished or abolished in the affected areas, but they may also be preserved in the initial attacks. There is no sensory deficit, although some patients occasionally present with paresthesias, and exceptionally with damage to the cranial nerves (especially CN XII). Receives: Other: high frequency ultrasound | |
| Patient with Anti-MAG | Anti-MAG is a demyelinating neuropathy characterized clinically by a chronic progressive distal and symmetrical predominantly sensory involvement. This neuropathy belongs to the group of symmetrical acquired demyelinating neuropathies (Distal Acquired Demyelinating Neuropathy (DADS)) which is distinguished from PIDC by: 1. an essentially distal and rather sensitive clinical involvement (unlike PIDC which is proximal and distal with predominantily motor involvement); 2. a strong association with a monoclonal gammopathy of the IgM type (67% of DADS vs 22% of PIDC according to Katz et al, 3. a poor therapeutic response to first line of immunosuppressive drugs (in contrast to PIDC which generally responds well). Certain electrophysiological parameters, such as the demonstration of demyelinating damage with accentuated slowing of distal nerve conduction, make it possible to distinguish anti-MAG neuropathy from CIDP. Receives: Other: high frequency ultrasound | |
| Patient with L-S | Lewis-Sumner syndrome is an acquired demyelinating polyradiculoneuritis characterised by distal asymmetric upper and lower limb weakness and motor dysfunction that develops in adulthood. It is considered a variant of chronic inflammatory demyelinating polyradiculoneuritis. It has a prevalence of 1-9 per 1,000,000. The diagnosis is made with electroneuromyography (ENMG) which shows marked and persistent conduction blocks, in at least two nerves, having an asymmetric topography, mainly affecting the upper limb, outside the usual areas of compression. Lower limb blocks are much rarer (anterior tibial nerve), and are always located below the fibular neck. Receives: Other: high frequency ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of nerve size using high frequency ultrasound
Size of cross section area (CSA) (mm) mesured in trasversal section of median and ulnar nerves at wrist, elbow and middle arm
Measured: 24 months
Secondary outcomes (6)
correlation between ultrasound data and clinical data
The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of motor deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - MRC-score allowing the assessment of the motor deficit. -
Measured: 24 months
correlation between ultrasound data and clinical data
The study of the correlation between ultrasound data (CSA) and clinical data (degree of functional impairment caused by the neuropathy) will be carried out on the basis of sensory deficit score obtained by using functional assessment scales and filling in a self-questionnaire: - INCAT for the evaluation of sensory deficit.
Measured: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Distal latency (in milliseconds);
Measured: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Motor conduction velocity (in m/s);
Measured: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Total and partial conduction block (reduction in the area and amplitude of the global muscle action potential expressed in percentage));
Measured: 24 months
Correlation between ultrasound data and electrophysiological data
The study of the correlation between the ultrasound data and the electrophysiological data will be carried out on the basis of the ultrasound scores obtained at the level of the predefined nerves and observation sites: - Reduction in the amplitude of the global muscle action potential (amplitude in mV)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978623
- Sponsor's protocol ID
- 21neuroperiph01
- Status last verified
- Mar 2025
- First submitted
- 20 Jul 2021
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Morphological Aspects of Nerve Fibers in Demyelinationg Polyneuropathies Using HIGH FREQUENCY Ultrasound
- ClinicalTrials.gov ID
- NCT04978623
- Acronym / sponsor ID
- 21neuroperiph01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Jul 2021 (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.
The use of neuroimaging in the evaluation of neuromuscular pathologies is a promising and rapidly expandinf field. Among the different imaging techniques employed, nerve ultrasound is of particular interest given it's non invasivity, lack of side effects, accesibility and low cost. This exam provides complementary data to electroneuromyography (ENMG), enabeling the physician to visualise the morphological correspondents of electrophysiological abnormalities with a spatial resolution at least as good as MRI.
Chronic Inflammatory Demyelinating Polyradiculoneuritis (CIDP), Multifocal Motor Neuropathy with Conduction Blocks (MMNBC), Lewis and Sumner syndrome (L-S syndrome) and anti-MAG antibody-associated neuropathies (anti-MAG) are among the main chronic inflammatory neuropathies of autoimmune etiology. The diagnosis of these diseases is based on clinical, paraclinical and ENMG examinations. Several recent studies have highlighted the valuable role of ultrasound not only in the diagnosis but also for follow up of patients afflicted by this group of diseases.
However, the current ultrasound imaging techniques does not allow for a detailed study of the internal structure of the nerves. The developement of technologies with improved resolution contribute to further the knowledge in this innovative field and to better understand the pathophysiological mechanisms responsible for initiation and progression of inflammatory nerve disorders.In the Department of Ultrasound at the Nice University Hospital in France the team have at its disposal a high frequency untrasound that the team use to explore the peripheral nervous system.
The scientific hypothesis of this pilot study rests on the premise that demyelinationg neuropathies are a heterogenous group where different types present with different morphological characteristics not only at the level of the nerve as a whole, but also at the level of the nerve fascicles and of the peri- and intra-neural vascular structures. In this respect, high frequency ultrasound allows us to visualise different segments of affected nerves and to obtain morphological details which the team then compare with existing ultrasound data in the literature (high frequency ultrasound: 10-20 MHz). Thanks to this non-invasive and painless technique, the nerve can be rapidly visualised along its entire length in static and dynamic mode. In addition, high frequency ultrasound will give us access to complementary data on the morphology of the soft tissues and the peri- and intra-neural vascular structures which may be useful in shedding light on the underlying pathophysiologycal processes. Another important aspect is the opportunity to make electromyographic and clinical correlations The main parameter The team will study in ultrasound will be hypertrophy, corresponding to an increase in the cross-sectional area of the nerve. the team will also conduct analysis on other less codified parameters, such as epineural and endoneural vascularisation (using the Doppler mode), as well as nerve fascicles anatomy (size, organisation). Identification of different characteristics may be of diagnostic interest in cases where the clinical, paraclinical and ENMG examinations do not allow us to make a diagnostic and therapeutic decision, but it can also prove useful in the follow-up of patients and response to treatment.
This is a descriptive, pilot, mono-centric, multiparametric and retrospective analysis study on patients followed in our centre with a diagnosis of CIDP, NMMBC, L-S syndrom and anti-MAG
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient with CIDP | – | Other: high frequency ultrasoundCIDP, is an acquired chronic inflammatory neuropathy characterised by : progressive symmetrical weakness of the proximal and to a lesser extent distal muscles of the lower and/or upper limbs, altered sensitivity and a decrease/abolition of the osteotendinous reflexes. The condition can be relapsing (30% of cases), chronically progressive (60%), or monophasically with total subsequent recovery (10%). Cranial nerve involvement is possible (5-30% of cases). Neuropathic pain as well as respiratory muscle and sub-clinical central nervous system involvement are described. |
| Patient with MMNCB | – | Other: high frequency ultrasoundPatients with MMNCB are at the crossroads between chronic demyelinating neuropathies and motor neuron diseases, the latter for which they constitute a differential diagnosis. The disease usually presents asymmetrically and affects the upper limbs more frequently. The course of the disease is unpredictable, and may be limited to one or two motor nerves or progress to other motor nerves in the contralateral upper limb and possibly the lower limbs. In all cases, the motor deficit is asymmetrical, multi-truncular in distribution, and is usually accompanied by cramps and fasciculations, and eventually by amyotrophy. Osteotendinous reflexes are usually diminished or abolished in the affected areas, but they may also be preserved in the initial attacks. There is no sensory deficit, although some patients occasionally present with paresthesias, and exceptionally with damage to the cranial nerves (especially CN XII). |
| Patient with Anti-MAG | – | Other: high frequency ultrasoundAnti-MAG is a demyelinating neuropathy characterized clinically by a chronic progressive distal and symmetrical predominantly sensory involvement. This neuropathy belongs to the group of symmetrical acquired demyelinating neuropathies (Distal Acquired Demyelinating Neuropathy (DADS)) which is distinguished from PIDC by: 1. an essentially distal and rather sensitive clinical involvement (unlike PIDC which is proximal and distal with predominantily motor involvement); 2. a strong association with a monoclonal gammopathy of the IgM type (67% of DADS vs 22% of PIDC according to Katz et al, 3. a poor therapeutic response to first line of immunosuppressive drugs (in contrast to PIDC which generally responds well). Certain electrophysiological parameters, such as the demonstration of demyelinating damage with accentuated slowing of distal nerve conduction, make it possible to distinguish anti-MAG neuropathy from CIDP. |
| Patient with L-S | – | Other: high frequency ultrasoundLewis-Sumner syndrome is an acquired demyelinating polyradiculoneuritis characterised by distal asymmetric upper and lower limb weakness and motor dysfunction that develops in adulthood. It is considered a variant of chronic inflammatory demyelinating polyradiculoneuritis. It has a prevalence of 1-9 per 1,000,000. The diagnosis is made with electroneuromyography (ENMG) which shows marked and persistent conduction blocks, in at least two nerves, having an asymmetric topography, mainly affecting the upper limb, outside the usual areas of compression. Lower limb blocks are much rarer (anterior tibial nerve), and are always located below the fibular neck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients in this study came to the Nice University Hospital in the Peripheral Nervous System and Muscle (SNPM) department for a consultation in the context of neuropathy. They were diagnosed with CIDP, MMNBC, anti-MAG and L-S and have undergone an ultrasound in addition to standard diagnosis protocol.
Key inclusion criteria (5 listed)
- Male or female,
- 18 years of age or older
- Patients with CIDP or NMMBC or definite anti-MAG neuropathy according to the criteria defined by EFNS 2010
- Signing of an informed consent.
- Affiliation or beneficiary of the social security system
Key exclusion criteria (7 listed)
- Subjects with a medical condition deemed by the investigator to interfere with the proper conduct of the study.
- Positive pregnancy test.
- Pregnant or breastfeeding woman (a urine pregnancy test will be performed for women of childbearing age) A urine The results will be communicated to the patient by a doctor of her choice.
- Persons deprived of their liberty by a judicial or administrative decision;
- Persons hospitalised without consent;
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 |
|---|---|---|
| high frequency ultrasoundhigh frequency ultrasound in subgroups of patients with CIDP, anti-MAG, NMMBC and L-S syndrome | Other | Patient with Anti-MAG, Patient with CIDP, Patient with L-S, Patient with MMNCB |
Primary outcome
Analysis of nerve size using high frequency ultrasound
Time frame: 24 months
Size of cross section area (CSA) (mm) mesured in trasversal section of median and ulnar nerves at wrist, elbow and middle arm
6 secondary outcomes
correlation between ultrasound data and clinical data
Time frame: 24 months
correlation between ultrasound data and clinical data
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
Time frame: 24 months
Correlation between ultrasound data and electrophysiological data
Time frame: 24 months
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 6 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Centre Hospitalier Universitaire de Nice 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 5 inclusion and 7 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 6 Mar 2025. 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?
Analysis of nerve size using high frequency ultrasound (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.