Quantification of Nerve Stiffness in Neuropathies

Not Applicable

• Conditions: Anti-MAG Neuropathy; Charcot-Marie-Tooth Disease, Type IA; Chronic Inflammatory Demyelinating Polyneuropathy
• Interventions: Other: elastography measurements

• Registration Number: NCT03397303
• Lead Sponsor: Nantes University Hospital

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02
• Study Start: 2018-04
• Primary Completion: 2020-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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)

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Exclusion Criteria

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
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	elastography measurements	-
patients with peripheral neuropathies	elastography measurements	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.

Primary Outcome Measures

Name	Time	Method
nerve shear wave velocity	Day0	Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.

Trial Locations

Locations (1)

Univeristy of Nantes; 🇫🇷 Nantes, France