Inflammatory Response in Children Suffering From Tethered Cord (TETHERIC)
20. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Lille, Frankrig
- CHU de LILLE
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
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,
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To describe the markers of chronic inflammation present in CSF collected at the beginning of surgery in children with attached low marrow.
Tidsramme: at the beginning of surgery
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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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of patients with the presence of at least one marker of inflammation present in the CSF collected at the end of surgery.
Tidsramme: 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
Tidsramme: 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.
Tidsramme: Immediately after surgery, 3 months after surgery and 6 months after surgery.
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Immediately after surgery, 3 months after surgery and 6 months after surgery.
|
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The NEM score measured preoperatively and immediately postoperatively
Tidsramme: Just before and immediately after surgery.
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Just before and immediately after surgery.
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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.
Tidsramme: Immediately after surgery, 3 months after surgery and 6 months after surgery
|
Immediately after surgery, 3 months after surgery and 6 months after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. maj 2024
Primær færdiggørelse (Faktiske)
5. januar 2026
Studieafslutning (Faktiske)
5. januar 2026
Datoer for studieregistrering
Først indsendt
13. oktober 2023
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Patologiske processer
- Neoplasmer
- Patologiske Tilstande, Anatomiske
- Neoplasmer efter histologisk type
- Medfødte abnormiteter
- Brok
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer, fedtvæv
- Misdannelser i nervesystemet
- Neuralrørsdefekter
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Betændelse
- Meningomyelocele
- Lipoma
- Meningocele
Andre undersøgelses-id-numre
- 2022_0561
Plan for individuelle deltagerdata (IPD)
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