Quantification of Nerve Stiffness in Neuropathies (Nerf_SSI)
Primary Purpose
Chronic Inflammatory Demyelinating Polyneuropathy, Charcot-Marie-Tooth Disease, Type IA, Anti-MAG Neuropathy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
elastography measurements
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility Criteria
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
Sites / Locations
- Univeristy of Nantes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
patients with peripheral neuropathies
controls
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03397303
First Posted
January 5, 2018
Last Updated
March 1, 2018
Sponsor
Nantes University Hospital
Collaborators
Université de Nantes
1. Study Identification
Unique Protocol Identification Number
NCT03397303
Brief Title
Quantification of Nerve Stiffness in Neuropathies
Acronym
Nerf_SSI
Official Title
Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Université de Nantes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyneuropathy, Charcot-Marie-Tooth Disease, Type IA, Anti-MAG Neuropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with peripheral neuropathies
Arm Type
Experimental
Arm Description
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.
Arm Title
controls
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
elastography measurements
Intervention Description
elastography measurements
Primary Outcome Measure Information:
Title
nerve shear wave velocity
Description
Ultrasound shear wave elastography will provide a measure of nerve shear wave velocity, which will be used as a surrogate of nerve stiffness.
Time Frame
Day0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yann Pereon, PUPH
Phone
33240083704
Email
yann.pereon@univ-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann Pereon, PU-PH
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François HUG
Email
francois.hug@univ-nantes.fr)
12. IPD Sharing Statement
Learn more about this trial
Quantification of Nerve Stiffness in Neuropathies
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