Quantification of Nerve Stiffness in Neuropathies (Nerf_SSI)

March 1, 2018 updated by: Nantes University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: controls
Other: elastography measurements
elastography measurements
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

Université de Nantes

Investigators

  • Principal Investigator: Yann Pereon, PU-PH, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

January 5, 2018

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 11, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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