ClinicalTrials.gg
WithdrawnNCT05257733CIDP echo-nerfUpdated Apr 5, 2024

Evaluation of the Diagnostic Contributions of Nerve Ultrasound in Chronic Inflammatory Demyelinating Polyneuropathy Associating Systemic Diseases (CIDP Echo-nerf)

An observational study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Centre Hospitalier Universitaire de Nīmes. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Why this study was withdrawn
Departure of the project leader
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

132 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 50 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 594 studies on the registry; 89 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients followed at Nîmes University Hospital between 2012 and 2021 with CIDP

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • CIDP associated with systemic diseases

    Patients with CIDP associated with systemic diseases

    Other: None, pure observationnal study

  • CIDP without systemic diseases

    Patients with CIDP without other systemic diseases

    Other: None, pure observationnal study

Interventions

  • OtherNone, pure observationnal study

    pure observationnal study

06

What researchers measure

Primary outcomes

  1. Median nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  2. ulnar nerve at wrist cross-sectional area

    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

    Time frame: Base line, Day 0

  3. ulnar at mid-arm nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  4. ulnar nerve at elbow cross-sectional area

    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

    Time frame: Base line, Day 0

  5. radial nerve cross-sectional area

    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

    Time frame: Day of diagnosis of CIDP

  6. superficial radial branch nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  7. vagus nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  8. C6 root nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  9. C5 root nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  10. sural nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  11. superficial fibula nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  12. tibial nerve at ankle cross-sectional area

    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

    Time frame: Base line, Day 0

  13. popliteal nerve cross-sectional area

    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

    Time frame: Base line, Day 0

  14. fibular nerve at neck cross-sectional area

    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

    Time frame: Base line, Day 0

  15. fibular at supra-neck nerve cross-sectional area

    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

    Time frame: Base line, Day 0

07

Study locations

1 site
  • CHU de Nîmes
    Nîmes, 30029, France
08

References and documents

Publications

  • Schmidt B, Toyka KV, Kiefer R, Full J, Hartung HP, Pollard J. Inflammatory infiltrates in sural nerve biopsies in Guillain-Barre syndrome and chronic inflammatory demyelinating neuropathy. Muscle Nerve. 1996 Apr;19(4):474-87. doi: 10.1002/(SICI)1097-4598(199604)19:43.0.CO;2-9. PubMed 8622727 ↗
  • Sommer C, Koch S, Lammens M, Gabreels-Festen A, Stoll G, Toyka KV. Macrophage clustering as a diagnostic marker in sural nerve biopsies of patients with CIDP. Neurology. 2005 Dec 27;65(12):1924-9. doi: 10.1212/01.wnl.0000188879.19900.b7. PubMed 16380614 ↗
  • Spies JM, Westland KW, Bonner JG, Pollard JD. Intraneural activated T cells cause focal breakdown of the blood-nerve barrier. Brain. 1995 Aug;118 ( Pt 4):857-68. doi: 10.1093/brain/118.4.857. PubMed 7655884 ↗
  • Madia F, Frisullo G, Nociti V, Conte A, Luigetti M, Del Grande A, Patanella AK, Iorio R, Tonali PA, Batocchi AP, Sabatelli M. pSTAT1, pSTAT3, and T-bet as markers of disease activity in chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst. 2009 Jun;14(2):107-17. doi: 10.1111/j.1529-8027.2009.00220.x. PubMed 19691533 ↗
  • Press R, Pashenkov M, Jin JP, Link H. Aberrated levels of cerebrospinal fluid chemokines in Guillain-Barre syndrome and chronic inflammatory demyelinating polyradiculoneuropathy. J Clin Immunol. 2003 Jul;23(4):259-67. doi: 10.1023/a:1024532715775. PubMed 12959218 ↗
  • Mei FJ, Ishizu T, Murai H, Osoegawa M, Minohara M, Zhang KN, Kira J. Th1 shift in CIDP versus Th2 shift in vasculitic neuropathy in CSF. J Neurol Sci. 2005 Jan 15;228(1):75-85. doi: 10.1016/j.jns.2004.10.001. Epub 2004 Nov 12. PubMed 15607214 ↗
  • Kurihara M, Kurata Y, Sugimoto I, Hatanaka Y, Sakurai Y. High PR3-ANCA positivity in a patient with chronic inflammatory demyelinating polyneuropathy. eNeurologicalSci. 2016 Oct 5;6:4-5. doi: 10.1016/j.ensci.2016.10.001. eCollection 2017 Mar. PubMed 29260006 ↗
  • Greenberg SA. P-ANCA vasculitic neuropathy with 12-year latency between onset of neuropathy and systemic symptoms. BMC Neurol. 2002 Oct 31;2(1):10. doi: 10.1186/1471-2377-2-10. PubMed 12437775 ↗
  • Abraham H, Kuzhively J, Rizvi SW. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): An Uncommon Manifestation of Systemic Lupus Erythematosus (SLE). Am J Case Rep. 2017 Sep 12;18:980-983. doi: 10.12659/ajcr.903541. PubMed 28894082 ↗
  • Siddiqui K, Cahalane E, Keogan M, Hardiman O. Chronic ataxic neuropathy with cold agglutinins: atypical phenotype and response to anti-CD20 antibodies. Neurology. 2003 Nov 11;61(9):1307-8. doi: 10.1212/wnl.61.9.1307. No abstract available. PubMed 14610153 ↗
  • Rodriguez Y, Vatti N, Ramirez-Santana C, Chang C, Mancera-Paez O, Gershwin ME, Anaya JM. Chronic inflammatory demyelinating polyneuropathy as an autoimmune disease. J Autoimmun. 2019 Aug;102:8-37. doi: 10.1016/j.jaut.2019.04.021. Epub 2019 May 6. PubMed 31072742 ↗
  • Wolbert J, Cheng MI, Meyer zu Horste G, Su MA. Deciphering immune mechanisms in chronic inflammatory demyelinating polyneuropathies. JCI Insight. 2020 Feb 13;5(3):e132411. doi: 10.1172/jci.insight.132411. PubMed 32051341 ↗
  • Seeliger T, Prenzler NK, Gingele S, Seeliger B, Korner S, Thiele T, Bonig L, Suhs KW, Witte T, Stangel M, Skripuletz T. Neuro-Sjogren: Peripheral Neuropathy With Limb Weakness in Sjogren's Syndrome. Front Immunol. 2019 Jul 11;10:1600. doi: 10.3389/fimmu.2019.01600. eCollection 2019. PubMed 31354737 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Dec 2023, 21 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2022
First posted
Feb 25, 2022
StartActual
Mar 15, 2022
Primary completionEst.
Dec 2023
CompletionEst.
Dec 2023
Last update
Apr 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05257733
Responsible party
Sponsor
First posted
Feb 25, 2022
Start date
Mar 15, 2022
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 5, 2024

Study contacts

Anissa MEGZARI
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion