EVALUATION OF SERUM INFLAMMATORY CYTOKINE CONCENTRATION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Compare serum interleukin IL-1β between different subgroups of patients with genetic neuropathy (demyelinating/axonal/intermediate Charcot-Marie-Tooth disease (CMT) and hereditary neuropathy with hypersensitivity to pressure (HNPP)) and a control group.
研究概览
简要总结
The most common forms of hereditary neuropathy are Charcot-Marie-Tooth disease (CMT) and hereditary neuropathy with hypersensitivity to pressure (HNPP) or tomacular neuropathy. A number of patients with one of these pathologies have inflammatory infiltrates in their nerves. Although the pathophysiology has not yet been well understood, the involvement of the immune system has been discussed. Nerve hypertrophy is the main anomaly described in ultrasound in demyelinating hereditary neuropathies and to a lesser extent in axonal forms. Investigators propose to understand if there is a circulating marker of inflammation in patients with CMT or HNPP and find a correlation between the increase in plasma pro-inflammatory cytokines and ultrasound changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •Patient over 18 years of age
- •Patient with CMT of HNPP with genetic confirmation, or acquired acute inflammatory disease such as Guillain-Barré syndrome
- •Patient able to walk alone or with a walking aid.
- •Patient affiliated to a social security scheme,
- •Patient who has given his consent in writing after written and oral information
- •Inclusion Criteria for Healthy Volunteers:
- •Patient over 18 years of age
- •Patient affiliated to a social security scheme,
- •Patient who has given his consent in writing after written and oral information -
排除标准
- •Subject protected by law under guardianship or curators, or not able to participate in a clinical study under article L. 1121-16 of the French Public Health Code;
- •Subject who has participated in a clinical research study during the last 3 months where he/she was exposed to a pharmaceutical product or medical device;
- •Subject who has stayed in a tropical or subtropical country during the last 3 months;
- •Pregnant or breastfeeding subject for women of childbearing age;
- •Subject who has been physically active for less than 10 hours;
- •Subject on a particular diet for medical reasons and prescribed by a doctor or dietitian (e.g., low-calorie or cholesterol-lowering diet);
- •Person who regularly consumes large amounts of alcohol, i.e. more than 50 g of pure alcohol per day (for example, more than 4 glasses of wine 150 ml, more than 4 beers 250 ml, or more than 4 glasses of 40 ml containing a strong alcohol);
- •Person who has used an illicit recreational drug in the last 3 months;
- •Subject who has taken an immunosuppressive or immunomodulatory drug (except for intranasal or topical corticosteroids) in the last 2 weeks, or for more than 14 consecutive days in the last 6 months;
- •Subject who has been vaccinated in the last 3 months;
- •Subject who received a blood transfusion or immunoglobulins in the last 3 months;
- •Person reporting not having fasted for at least 10 hours;
- •Person reporting human immunodeficiency virus, hepatitis B virus or hepatitis C virus ;
- •Subject who has had an infectious episode in the 3 weeks preceding the visit;
- •Test positive for pregnancy urine;
- •Subject with severe and/or chronic and/or recurrent disease
- •Subject diagnosed with cancer and not in remission for more than 5 years.
- •(only for patients) Other associated peripheral nerve pathology already diagnosed (inherited neuropathy or acquired neuropathy from another etiology).
- •(only for Health volunteers) Presence of functional or physical signs of involvement of the median nerves, ulnar, external Sciatica Poplitea, internal Sciatica Poplitea, sural
研究组 & 干预措施
Identify a circulating marker of inflammation in patients with CMT or HNPP
CMT = Charcot-Marie-Tooth disease HNPP = hereditary neuropathy with hypersensitivity to pressure
干预措施: blood test for pro-inflammatory cytokines and ultrasound of the median nerves (Diagnostic Test)
结局指标
主要结局
Compare serum interleukin IL-1β between different subgroups of patients with genetic neuropathy (demyelinating/axonal/intermediate Charcot-Marie-Tooth disease (CMT) and hereditary neuropathy with hypersensitivity to pressure (HNPP)) and a control group.
时间窗: at inclusion
Serum interleukin IL-1β will be measured using v-plex MSD (Meso Scale Discovery) technology. The IL-1β concentrations will be expressed in ng/ml by calibration with a standard range
次要结局
- Compare the serum concentration of pro-inflammatory cytokines among the different subgroups of patients with genetic neuropathy (demyelinating/axonal/intermediate CMT, HNPP) and with a homogeneous group of control subjects.(at inclusion)
- Compare morphological characteristics obtained by high-frequency ultrasound between the different subgroups of subjects(within 2 months after inclusion)
- Study the relationship between ultrasound data and plasma levels of pro-inflammatory cytokines within the different subgroups of subjects(within 2 months after inclusion)
- Study the link between the plasma level of pro-inflammatory cytokines and electrophysiological data obtained by performing electroneurography (ENG) within the different subgroups of subjects(within 2 months after inclusion)
- Study the relationship between ultrasound and electrophysiological data obtained by an electroneurography (ENG) within the different subgroups of subjects(within 2 months after inclusion)
- Study the relationship between serum concentration of pro-inflammatory cytokines among the different subgroups of patients and clinical scores within different subgroups of subjects using functional assessment scale CMT Neuropathy Score 2 (CMTNS2)(within 2 months after inclusion)
- Study the relationship between ultrasound data and the iMAX value: Study the relationship between ultrasound data and IMAX value.(within 2 months after inclusion)