Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome (NEUROSS)
The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases. Among peripheral nervous system complication, SFN appears to be prevalent. However the association between pSS and SFN has been scarcely evaluated. There are not many relevant studies using similar methodology to evaluate pSS patients for small fiber dysfunction. Furthermore, autoimmune mechanisms are thought to play a key role in SFN pathogenesis in pSS and the association between SFN and specific immunological profiles has been poorly studied. So the aim of this study is to evaluate the prevalence of SFN in pSS patients by using the Sudoscan which is a fast and non- invasive tool. The Sudoscan could offer an accessible alternative for early SFN detection, improving patient management. The secondary purpose is to analyze systemic and immunological profiles, as well as disease's activity and quality of life of patients with pSS-related SFN.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Valéry SALLE, MD
- 电话号码:33+3 22 66 82 30
- 邮箱:salle.valery@chu-amiens.fr
学习地点
-
-
-
Amiens、法国、80054
- 招聘中
- CHU Amiens
-
接触:
- Valéry SALLE, PhD
- 电话号码:03 22 66 88 22
- 邮箱:Salle.Valery@chu-amiens.fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years
- Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016
- Body Mass Index between 18 and 35 kg/m²
Exclusion Criteria:
- Secondary or unconfirmed Sjögren's syndrome,
- Age < 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion,
- Other conditions that may cause small fiber neuropathy,
- type 2 diabetes,
- excessive alcohol consumption,
- sarcoidosis
- obesity
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
prevalence of SFN in patients with pSS
大体时间:18 months
|
To assess the prevalence of SFN in patients with pSS |
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
time of onset of peripheral neuropathies
大体时间:1 day
|
1 day
|
|
|
correlation of clinical features correlation with neuropathy severity
大体时间:18 months
|
correlation of clinical features correlation with neuropathy severity |
18 months
|
|
correlation of immunological profile with neuropathy severity
大体时间:18 months
|
correlation of immunological profile with neuropathy severity |
18 months
|
|
correlation of disease's activity with the quality of life
大体时间:18 months
|
correlation of disease's activity with the quality of life |
18 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PI2025_843_0185
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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