Chronic Inflammatory Demyelinating PolyneuropathyNerf_SSINCT03397303
Quantification of Nerve Stiffness in Neuropathies
A study testing elastography measurements in people with Chronic Inflammatory Demyelinating Polyneuropathy and Charcot-Marie-Tooth Disease, Type IA, run by Nantes University Hospital at 1 site in France.
Trial summary
This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyneuropathy, Charcot-Marie-Tooth Disease, Type IA, Anti-MAG Neuropathy
- What is being tested?
- elastography measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2018to 8 Dec 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65
- Having social insurance status
- Having given informed consent
- Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)>15,000 BTU)
Who cannot join
- For controls:
- Person staying in a health or social facility
- Person unable to understand the protocol and to respect the modalities
- Person deprived of liberty
- Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
- Participation in another biomedical research in progress
Show all 20Show fewer
- Diabetes, history of neuromuscular disease
- For CIDP:
- Person staying in a health or social facility
- Person unable to understand the protocol and to respect the modalities
- Person deprived of liberty
- Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
- Participation in another biomedical research in progress
- MRC score < 3
- For Charcot-Marie-Tooth type 1 (CMT1) and anti-MAG:
- Person staying in a health or social facility
- Person unable to understand the protocol and to respect the modalities
- Person deprived of liberty
- Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
- Participation in another biomedical research in progress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies
This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.
Read the detailed description
The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.
Participants will be asked to remain relaxed during elastography measurements.
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Charcot-Marie-Tooth Disease, Type IA, Anti-MAG Neuropathy
- Being tested
- elastography measurements
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastography measurementsOther
elastography measurements
| Study group | Role | What they receive |
|---|---|---|
| patients with peripheral neuropathies | Experimental | This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls. Receives: Other: elastography measurements |
| controls | Other | Not described Receives: Other: elastography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
nerve shear wave velocity
Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.
Measured: Day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start11 Apr 2018
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Demyelinating PolyneuropathyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Nantes
- Responsible party
- Sponsor
- Investigators
- Yann Pereon, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397303
- Sponsor's protocol ID
- RC17_0231
- Acronym
- Nerf_SSI
- Status last verified
- Jan 2025
- First submitted
- 5 Jan 2018
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andrade RJ, Nordez A, Magot A, Couloume L, Plancon JP, Quillard JB, Ware RS, Coppieters MW, Pereon Y, Hug F. Ultrasound Shear Wave Velocity of Peripheral Nerves: A Possible Non-Invasive Biomarker for Demyelinating Neuropathies. J Peripher Nerv Syst. 2025 Jun;30(2):e70015. doi: 10.1111/jns.70015.
PubMed 40189914
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies
- ClinicalTrials.gov ID
- NCT03397303
- Acronym / sponsor ID
- Nerf_SSI / RC17_0231
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, Charcot-Marie-Tooth Disease, Type IA, Anti-MAG Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Université de Nantes
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 11 Jan 2018 (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.
This project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls.
Detailed description
The following nerve will be studied bilaterally, in a randomised order: Median, ulnar, Radial, Sciatic and Tibial.
Participants will be asked to remain relaxed during elastography measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with peripheral neuropathies | Experimental | Other: elastography measurementsThis project aims to understand how nerve mechanical properties are altered in patients with rare peripheral neuropathies . Stiffness of various peripheral nerves will be measured using ultrasound shear wave elastography. Patients will be compared with age-matched controls. |
| controls | Other | Other: elastography measurements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 to 65
- Having social insurance status
- Having given informed consent
- Diagnostic of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), CMT1a or Anti-MAG (peak immunoglobulin M (IGm)>15,000 BTU)
Key exclusion criteria (20 listed)
- Person staying in a health or social facility
- Person unable to understand the protocol and to respect the modalities
- Person deprived of liberty
- Person of legal age benefiting from a system of legal protection (guardianship, curators or safeguard of justice)
- Participation in another biomedical research in progress
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 |
|---|---|---|
| elastography measurementselastography measurements | Other | controls, patients with peripheral neuropathies |
Primary outcome
nerve shear wave velocity
Time frame: Day0
Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.
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 14 Sep 2026.
- Results publication: PubMed 40189914Andrade RJ, Nordez A, Magot A, Couloume L, Plancon JP, Quillard JB, Ware RS, Coppieters MW, Pereon Y, Hug F. Ultrasound Shear Wave Velocity of Peripheral Nerves: A Possible Non-Invasive Biomarker for Demyelinating Neuropathies. J Peripher Nerv Syst. 2025 Jun;30(2):e70015. doi: 10.1111/jns.70015.
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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.
Yann Pereon, PU-PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastography measurements in people with Chronic Inflammatory Demyelinating Polyneuropathy and Charcot-Marie-Tooth Disease, Type IA, run by Nantes University Hospital 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 20 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 14 Sep 2026. 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?
nerve shear wave velocity (time frame: Day0). 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 NCT03397303, which also lists 1 linked publication.
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 14 Sep 2026.