Skip to main content
Clinical Trials/NL-OMON30708
NL-OMON30708
Recruiting
Not Applicable

Peripheral Neuropathy Outcome Measures Standardisation Study - PeriNomS study

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
peripheral nerve lesion
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
170
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- patients must have clear consciousness
  • \- patients must meet the international criteria for their diagnosis
  • \- written informed consent given by the participant is mandatory before inclusion
  • \- patients with newly diagnosed GBS, CIDP, MGUSP or MMN will be included in the longitudinal part of the study
  • \- patients with CIDP demonstrating a clinical relapse, and not using any medication for their polyneuropathy (e.g. intravenous immunoglobulins, steroids, immunosuppressive agent) for at least 2 months prior to inclusion, can be included in the longitudinal part of the study
  • \- patients with MMN having new (multi)focal nerve lesion, not using any medication for their polyneuropathy (e.g. intravenous immunoglobulins) for at least 2 months prior to inclusion, can also be included in the longitudinal part of the study
  • \- MGUSP: in both parts of the study, patients will only be included in the MGUSP group if they have serologically proven IgM anti\-MAG\+ antibodies. For the longitudinal study group MGUSP patients must have an indication for therapy (on basis of clear progression of symptoms)
  • \- patients with a clinical diagnosis and a clinical course compatible with CIDP and an IgG MGUSP will be included as CIDP (in both parts of the study)
  • \- for the cross\-sectional part of the study, patients with the following diseases will be included: GBS, CIDP, MMN, MGUSP, and AI\-SFN in sarcoidosis. Only patients with a clinical stable condition will be included. A clinical stable condition is defined as:
  • 1\) An unchanged clinical functionality as declared by the patient to the best of his/her knowledge over 2 months prior to the study and during the study (stable condition at second visit compared to entry)

Exclusion Criteria

  • \- age \< 18 years
  • \- concomitant disease (e.g. diabetes, renal insufficiency), (prior) treatment with chemotherapy or alcohol abuse that might interfere with general nervous system as well as physical functioning
  • \- patients with an IgM MGUSP without serologically proven IgM anti\-MAG\+ antibodies will be excluded for both parts of the study

Outcomes

Primary Outcomes

Not specified

Similar Trials