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Quantification of Nerve Stiffness in Neuropathies (Nerf_SSI)

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ClinicalTrials.gov Identifier: NCT03397303
Recruitment Status : Not yet recruiting
First Posted : January 11, 2018
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Université de Nantes
Information provided by (Responsible Party):
Nantes University Hospital

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 Not Applicable

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  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


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

controls Other: elastography measurements
elastography measurements




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397303


Contacts
Contact: Yann Pereon, PUPH 33240083704 yann.pereon@univ-nantes.fr

Locations
France
Univeristy of Nantes Not yet recruiting
Nantes, France, 44093
Contact: François HUG       francois.hug@univ-nantes.fr)   
Sponsors and Collaborators
Nantes University Hospital
Université de Nantes
Investigators
Principal Investigator: Yann Pereon, PU-PH Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03397303     History of Changes
Other Study ID Numbers: RC17_0231
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Polyneuropathies
Tooth Diseases
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Stomatognathic Diseases
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases