Inflammatory Response in Children Suffering From Tethered Cord

NCT07611058 | Completed

• 1 other identifier: 2022_0561
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele

Keywords

Tethered spinal cord; pediatric neurosurgery; inflammation; procteomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

all patients who are to undergo surgery for tethered spinal cord

EXPERIMENTAL

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

Interventions

CSF sampling during surgery PROCEDURE

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.

all patients who are to undergo surgery for tethered spinal cord

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

chu de Lille

Lille, France

Location

MeSH Terms

Conditions

Lipoma; Meningomyelocele; Meningocele; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: May 28, 2026
• Study Start: May 16, 2024
• Primary Completion: January 5, 2026
• Study Completion: January 5, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)