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Completed

NCT Number: NCT03397303

Quantification of Nerve Stiffness in 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.

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Key information

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy Anti-MAG Neuropathy Autoimmune Diseases Autoimmune Diseases of the Nervous System Charcot-Marie-Tooth Disease Charcot-Marie-Tooth Disease, Type IA Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Diseases Disease Attributes Genetic Diseases, Inborn Hereditary Sensory and Motor Neuropathy Heredodegenerative Disorders, Nervous System Immune System Diseases Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

elastography measurements

Other

elastography measurements

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Université de Nantes

Registry information

Official study title

Quantification of Nerve Stiffness in Patients with Peripheral Neuropathies

Acronym: Nerf_SSI

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2018
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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