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Clinical Trials/NCT05257733
NCT05257733
Withdrawn
Not Applicable

Evaluation of the Diagnostic Contributions of Nerve Ultrasound in Chronic Inflammatory Demyelinating Polyneuropathy Associating Systemic Diseases

Centre Hospitalier Universitaire de Nīmes1 site in 1 countryMarch 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Sponsor
Centre Hospitalier Universitaire de Nīmes
Locations
1
Primary Endpoint
vagus nerve cross-sectional area
Status
Withdrawn
Last Updated
2 years ago

Overview

Brief Summary

Chronic inflammatory demyelinating polyradiculoneuritis (CIDP) is an autoimmune disorder of the peripheral nervous system, most commonly affecting the myelin sheath. The pathophysiology of CIDP is not completely understood, but both humoral and cellular immunity appear to be involved in the genesis of this disease. Some diseases are particularly associated with CIDP such as diabetes, monoclonal gammopathies and hematological diseases.

CIDP can occur before, after or simultaneously with the onset of systemic diseases. The systemic diseases most often seen in association with polyneuropathies are lupus, Gougerot-Sjögren's syndrome and sarcoidosis.

Ultrasound of peripheral nerves is a useful and accessible tool. In CIDP, this examination can reveal diffuse or segmental nerve hypertrophy. In addition to the size of the nerve, this exploration analyzes the echogenicity and the aspect of the different fascicles within the nerve. S. Goedee et al have shown that nerve ultrasound has very good diagnostic parameters and low interobserver variability in the diagnosis of CIDP. F. Härtig et al suggests that nerve ultrasound can predict the therapeutic response and describes 3 main patterns: hypoechoic enlargement (active inflammation), nerve enlargement with hyperechoic add-on fascicles (axonal degeneration) and almost no enlargement ("cured" CIDP).

Detailed Description

CIDP may be progressive or relapsing, most frequently clinically symmetric, sensorimotor with proximal and distal involvement developing over at least 8 weeks but variants as distal, multifocal, focal, motor or sensory CIDP have been also described. Cell-mediated and humoral mechanisms act together in an aberrant immune response to cause damage to peripheral nerves but, by molecular mimicry it causes other autoimmune system diseases. This paper focuses on the intersection of CIDP and other autoimmune disease with an emphasis on shared pathology and mutually characteristics.

Registry
clinicaltrials.gov
Start Date
March 15, 2022
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients followed at Nîmes University Hospital between 2012 and 2021
  • Age \> 18 years
  • Diagnosis of definite CIDP or possible CIDP according to the new EFNS/PNS 2021 criteria
  • Diagnosis of definite CIDP/CIDP possible with systemic diseases and respectively diagnosis of definite CIDP/CIDP possible for the control group confirmed by electroneuromyography, concordant with the clinical examination

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

vagus nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of vagus nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

C5 root nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of C5 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

Median nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of median nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

ulnar at mid-arm nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of ulnar nerve at mid-arm cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

radial nerve cross-sectional area

Time Frame: Day of diagnosis of CIDP

Comparison of radial nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

ulnar nerve at wrist cross-sectional area

Time Frame: Base line, Day 0

Comparison of ulnar nerve at wrist cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

ulnar nerve at elbow cross-sectional area

Time Frame: Base line, Day 0

Comparison of ulnar nerve at elbow cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

superficial radial branch nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of superficial radial branch nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

sural nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of sural nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

superficial fibula nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of superficial fibula nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

C6 root nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of C6 root nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

fibular nerve at neck cross-sectional area

Time Frame: Base line, Day 0

Comparison of fibular nerve at neck cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

fibular at supra-neck nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of fibular at supra-neck nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

tibial nerve at ankle cross-sectional area

Time Frame: Base line, Day 0

Comparison of tibial nerve at ankle cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

popliteal nerve cross-sectional area

Time Frame: Base line, Day 0

Comparison of popliteal nerve cross-sectional area on nerve ultrasound in patients with definite PIDC/PIDC with associated systemic disease with that of patients with PIDC/PIDC without systemic disease

Study Sites (1)

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