NL-OMON30708招募中不适用
Peripheral Neuropathy Outcome Measures Standardisation Study - PeriNomS study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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)
排除标准
- •- 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
研究者
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