Quantification of Nerve Stiffness in Neuropathies | NCT03397303

Studies
Quantification of Nerve Stiffness in Neuropathies

NCT03397303

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jan 27, 2025Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

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

Interventions

elastography measurements

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2018Actual

Primary Completion Date

Dec 8, 2023Actual

Completion Date

Dec 8, 2023Actual

First Submitted Date

Jan 5, 2018

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 27, 2025Actual

Name	Class
Université de Nantes	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
elastography measurements	Other	elastography measurements	controls patients with peripheral neuropathies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yann Pereon, PU-PH	Nantes University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy of Nantes		Nantes		44093	France

Condition Browse Module

MeSH Terms

ID	Term
D020277	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
D002607	Charcot-Marie-Tooth Disease

Ancestor Terms

ID	Term
D011129	Polyradiculoneuropathy
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided