Quantification of Nerve Stiffness in Neuropathies

Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial

— Nerf_SSI  

Official title:

Quantification of Nerve Stiffness in Patients With Peripheral Neuropathies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03397303
• Other study ID #: RC17_0231
• Status: Not yet recruiting
• Phase: N/A
• First received: January 5, 2018
• Last updated: March 1, 2018
• Start date: April 2018
• Est. completion date: April 2020

Study information

• Verified date: March 2018
• Source: Nantes University Hospital
• Contact: Yann Pereon, PUPH
• Phone: 33240083704
• Email: yann.pereon[@]univ-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anti-MAG Neuropathy
• Charcot-Marie-Tooth Disease
• Charcot-Marie-Tooth Disease, Type IA
• Chronic Inflammatory Demyelinating Polyneuropathy
• Hereditary Sensory and Motor Neuropathy
• Nerve Compression Syndromes
• Polyneuropathies
• Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
• Tooth Diseases

Intervention

Other:
• elastography measurements
elastography measurements

Locations

Country	Name	City	State
France	Univeristy of Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Université de Nantes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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