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Peripheral Neuropathy Outcome Measures Standardisation Study

Peripheral Neuropathy Outcome Measures Standardisation Study - PeriNomS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30708
Enrollment
170
Registered
2007-03-05
Start date
2007-04-04
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

peripheral nerve lesion polyneuropathy

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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) 2) No clear objective changes at neurological examination by the researcher when compared with recorded findings over two month prior to study entry (if available) and during the study (unchanged neurological examination at second visit compared to entry) - for the cross-sectional study, the selected patients must still have residual symptoms or signs due to their illness that represents a broad range of activity limitations before admission to the current study - patients with CIDP or MMN receiving (interval) therapy can be included in the cross-sectional part of the study as long as their clinical condition is stable (see definition above)

Exclusion criteria

Exclusion criteria: - age

Design outcomes

Primary

MeasureTime frame
The selected outcome measures will be evaluated on their applicability, validity, reliability and responsiveness. They are the most important study parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)