Inflammatory Response in Children Suffering From Tethered Cord (TETHERIC)

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.

Study Overview

• Status: Completed
• Conditions: Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele
• Intervention / Treatment: Procedure: CSF sampling during surgery

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHU de LILLE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: CSF sampling during surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the markers of chronic inflammation present in CSF collected at the beginning of surgery in children with attached low marrow.	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with the presence of at least one marker of inflammation present in the CSF collected 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	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.	Immediately after surgery, 3 months after surgery and 6 months after surgery.
The NEM score measured preoperatively and immediately postoperatively	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.	Immediately after surgery, 3 months after surgery and 6 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Actual): January 5, 2026
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: inflammation; Tethered spinal cord; pediatric neurosurgery; procteomics
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Congenital Abnormalities; Hernia; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Nervous System Malformations; Neural Tube Defects; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Inflammation; Meningomyelocele; Lipoma; Meningocele
• Other Study ID Numbers: 2022_0561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No