Nerf_SSI: Quantification of Nerve Stiffness in Neuropathies

Sponsor

Nantes University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03397303

Collaborator

Université de Nantes (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy Charcot-Marie-Tooth Disease, Type IA Anti-MAG Neuropathy	Other: elastography measurements	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: elastography measurements elastography measurements
Other: controls	Other: elastography measurements elastography measurements

Arm

Intervention/Treatment

Experimental: patients with peripheral neuropathies

Other: elastography measurements

elastography measurements

Other: controls

Other: elastography measurements

elastography measurements

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

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