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NCT Number: NCT07611058

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.

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Key information

Conditions

Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Inflammation Lipoma Meningocele Meningomyelocele Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Nervous System Diseases Nervous System Malformations Neural Tube Defects Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

chu de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

    Time frame: 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.

Secondary outcomes

  1. Proportion of patients with the presence of at least one marker of inflammation present in the CSF collected at the end of surgery.

    Time frame: at the end of surgery

  2. 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

    Time frame: at the end of surgery

  3. 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.

    Time frame: Immediately after surgery, 3 months after surgery and 6 months after surgery.

  4. The NEM score measured preoperatively and immediately postoperatively

    Time frame: Just before and immediately after surgery.

  5. 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.

    Time frame: Immediately after surgery, 3 months after surgery and 6 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Study of Inflammatory Response in Children Suffering From Tethered Cord

Acronym: TETHERIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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