Quantification of Nerve Stiffness in Neuropathies

NCT03397303 | Completed

• 1 other identifier: RC17_0231
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy; Charcot-Marie-Tooth Disease, Type IA; Anti-MAG Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Day0

Study Arms (2)

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.

Other: elastography measurements

controls

OTHER

Other: elastography measurements

Interventions

elastography measurements OTHER

elastography measurements

controls; patients with peripheral neuropathies

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Nantes University Hospital: lead
• Université de Nantes: collaborator

Study Sites (1)

Univeristy of Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Yann Pereon, PU-PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 11, 2018
• Study Start: April 11, 2018
• Primary Completion: December 8, 2023
• Study Completion: December 8, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)