Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy

NCT ID: NCT05219383

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-12-31

Brief Summary

Chronic dysimmune neuropathies (CDN) are a heterogenous group of acquired inflammatory demyelinating neuropathies including chronic inflammatory demyelinating polyneuropathies (CIDP), Lewis-Sumner Syndrome (LSS), multifocal motor neuropathy (MMN) and other rare entities.

Despite their relatively low prevalence, CDN lead to substantial costs for patients and society. CDN are usually misdiagnosed due to progressive nature of the disease with little known data regarding disease activity and treatment response

Detailed Description

CIDP is the most common treatable CDN worldwide. Its prevalence is ranging between approximately 1 to 8.9 cases per 100.000 . In addition, there is often the tendency to diagnose CIDP in order to attempt a treatment option. This ultimately leads to overdiagnosis and overtreatment in some patients

Although the different CDN have varying underlying pathophysiology and clinical characteristics, they are all potentially treatable with immunomodulatory drugs.

To date, diagnostic criteria, measurement of disease activity and treatment response of CDN are mainly based on clinical, electrophysiological, and patient related outcome parameters. The commonly used EFNS/PNS diagnostic criteria for CIDP seems to have the best sensitivity among different sets of diagnostic criteria

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Age > 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months

Exclusion Criteria

• *Patients with systemic diseases (DM, chronic kidney or liver disease, thyroid disease, vitamin B12 deficiency)

• Family history of peripheral neuropathy or neurological symptoms suggestive for heredo-familial neurological disorders
• Patients with infective cause as (HBV, HCV, HIV, leprosy)
• Toxic and drug induced polyneuropathy (chemotherapeutics, antimicrobial ..

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yousef Josef Louis Megalla

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Rajabally YA, Nicolas G, Pieret F, Bouche P, Van den Bergh PY. Validity of diagnostic criteria for chronic inflammatory demyelinating polyneuropathy: a multicentre European study. J Neurol Neurosurg Psychiatry. 2009 Dec;80(12):1364-8. doi: 10.1136/jnnp.2009.179358. Epub 2009 Jul 20.

Reference Type: BACKGROUND

PMID: 19622522 (View on PubMed)

Breiner A, Brannagan TH 3rd. Comparison of sensitivity and specificity among 15 criteria for chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2014 Jul;50(1):40-6. doi: 10.1002/mus.24088. Epub 2013 Dec 11.

Reference Type: BACKGROUND

PMID: 24338746 (View on PubMed)

Hartung HP, Lehmann HC, Willison HJ. Peripheral neuropathies: Establishing common clinical research standards for CIDP. Nat Rev Neurol. 2011 May;7(5):250-1. doi: 10.1038/nrneurol.2011.46. Epub 2011 Apr 12. No abstract available.

Reference Type: BACKGROUND

PMID: 21537353 (View on PubMed)

Other Identifiers

Chronic dysimmune neuropathy

Identifier Type: -

Identifier Source: org_study_id