An interventional study of CSF sampling during surgery in Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Basic science
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.
22 studies on the registry are indexed under Lipoma; 6 are open to participants now.
This study's enrollment of 32 is close to the median of 30 across 17 interventional studies indexed under Lipoma.
Browse Lipoma studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
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.
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.
Time frame: at the beginning of surgery
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
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
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.
The NEM score measured preoperatively and immediately postoperatively
Time frame: 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.
Time frame: Immediately after surgery, 3 months after surgery and 6 months after surgery
Plan to share: No
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Ran from May 2024 to primary completion in Jan 2026, 19 months.
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