Quantification of Nerve Stiffness in Neuropathies

NCT ID: NCT03397303

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2023-12-08

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

elastography measurements

Intervention Type OTHER

elastography measurements

controls

Group Type OTHER

elastography measurements

Intervention Type OTHER

elastography measurements

Interventions

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elastography measurements

elastography measurements

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Nantes

OTHER

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yann Pereon, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Univeristy of Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC17_0231

Identifier Type: -

Identifier Source: org_study_id

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