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临床试验/NCT03396783
NCT03396783已完成不适用

Characterization of the Immunological Profile Patients With Post-polio Syndrome in Comparison With These Control Subjects

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2017年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
lymphocytes blood concentrations

研究概览

简要总结

Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
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

入选标准

  • Subjects with Post-polio Syndrome :
  • age ≥ 18 years
  • meeting the definition of the SPP according to the criteria of Halstead et al. (1995)
  • Controlled subjects :
  • age ≥ 18 years
  • matched on sex and age (+/- 5 years) with subjects with PPS

排除标准

  • intercurrent neurological pathology,
  • uncontrolled cardiovascular risk factors
  • pulmonary comorbidity
  • endocrine disorders
  • systemic inflammatory pathology, autoimmune disease, dry syndrome,
  • renal failure
  • anti-inflammatory treatment in progress or in the previous month, or immunoregulatory aim whatever its nature,
  • patients with SPP who received polyvalent IV immunoglobulins in the 3 years prior to inclusion, or taking anticoagulants

结局指标

主要结局

lymphocytes blood concentrations

时间窗: blood sample during inclusion visit

cytokines blood concentrations

时间窗: blood sample during inclusion visit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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