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.
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
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