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Inflammatory Response in Children Suffering From Tethered Cord (TETHERIC)

2026年5月20日 更新者:University Hospital, Lille

Study of Inflammatory Response in Children Suffering From Tethered Cord

Embryologic phenomenons that lead to dysraphisms are known, but pathophysiology remains questioned. It is supposed not to be a simple mechanistic dysfunction, and other biological phenomenons are implied in spinal cord damaging. Two main hypothesis are that manual deformation of the cells and mitochondrial membranes lead to energy deficiency and blood flow changes. On the other hand, considering traumatic spinal cord injuries (SCI), inflammation has been shown to have dramatic effects on spinal cord function and physiology. Indeed, all essays about SCI have demonstrated that the initial trauma leads to mechanical injury to cells, accompanied by damages of microvasculature, initiation of pro-apoptotic signaling and ischemia. Therefore, we could imagine that similar inflammatory processes can be implied in stretched spinal cord. In our review of literature, we found few papers highlighting the question of inflammation and CSF sampling.

研究概览

研究类型

介入性

注册 (实际的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lille、法国
        • CHU de Lille

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Infants and children under 18 years of age
  • Carriers of an attached marrow: lipomatous fiilum, meningocele, myelomeningocele, myelolipoma,
  • Consent of the child's parents,
  • Socially insured patient,
  • Patient willing to comply with all study procedures and duration,

Exclusion Criteria:

  • Patients over 18 years of age,
  • Chronic inflammatory disease,
  • Ongoing anti-inflammatory treatments,
  • No parental consent,

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:all patients who are to undergo surgery for tethered spinal cord
Experimental group: all patients who are to undergo surgery for tethered spinal cord, including thickened filum, lipomas, myelomeningocele and meningocele
Proteomic studies will be led on the CSF samples, to identify inflammatory peptides and cells. The proteomic study will be correlated to clinical pre and post-operative data.

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
To describe the markers of chronic inflammation present in CSF collected at the beginning of surgery in children with attached low marrow.
大体时间:at the beginning of surgery
Proportion of patients with the presence of at least one marker of inflammation present in CSF collected at the beginning of surgery.
at the beginning of surgery

次要结果测量

结果测量
大体时间
Proportion of patients with the presence of at least one marker of inflammation present in the CSF collected at the end of surgery.
大体时间:at the end of surgery
at the end of surgery
Proportion of patients with the presence of at least one marker of inflammation present in the CSF collected at the beginning of surgery and the proportion of patients with the presence of at least one marker of inflammation at the end of surgery
大体时间:at the end of surgery
at the end of surgery
The clinical outcome assessed by the NEM score in postoperative patients, immediately after surgery,3 months after surgery and 6 months after will be evaluated by the clinician in charge of the patient.
大体时间:Immediately after surgery, 3 months after surgery and 6 months after surgery.
Immediately after surgery, 3 months after surgery and 6 months after surgery.
The NEM score measured preoperatively and immediately postoperatively
大体时间:Just before and immediately after surgery.
Just before and immediately after surgery.
The postoperative NEM score (immediately after surgery, 4 months after surgery and 18 months after) between patients with at least one of the inflammatory markers present and patients without inflammatory markers.
大体时间:Immediately after surgery, 3 months after surgery and 6 months after surgery
Immediately after surgery, 3 months after surgery and 6 months after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年5月16日

初级完成 (实际的)

2026年1月5日

研究完成 (实际的)

2026年1月5日

研究注册日期

首次提交

2023年10月13日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月28日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月20日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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