Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and MeningoceleTETHERICNCT07611058
Inflammatory Response in Children Suffering From Tethered Cord
A study testing CSF sampling during surgery in people with Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele
- What is being tested?
- CSF sampling during surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2024to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Who cannot join
- Patients over 18 years of age,
- Chronic inflammatory disease,
- Ongoing anti-inflammatory treatments,
- No parental consent,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele
- Being tested
- CSF sampling during surgery
- Keywords
- Tethered spinal cord, pediatric neurosurgery, inflammation, procteomics
- Medical subject headings
- Lipoma, Meningomyelocele, Meningocele, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF sampling during surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: CSF sampling during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Immediately after surgery, 3 months after surgery and 6 months after surgery.
The NEM score measured preoperatively and immediately postoperatively
Measured: 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.
Measured: Immediately after surgery, 3 months after surgery and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start16 May 2024
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and MeningoceleStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611058
- Sponsor's protocol ID
- 2022_0561
- Acronym
- TETHERIC
- Status last verified
- May 2026
- First submitted
- 13 Oct 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Inflammatory Response in Children Suffering From Tethered Cord
- ClinicalTrials.gov ID
- NCT07611058
- Acronym / sponsor ID
- TETHERIC / 2022_0561
- Conditions
- Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele
- Keywords
- Tethered spinal cord, pediatric neurosurgery, inflammation, procteomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients who are to undergo surgery for tethered spinal cord | Experimental | Procedure: CSF sampling during surgeryExperimental group: all patients who are to undergo surgery for tethered spinal cord, including thickened filum, lipomas, myelomeningocele and meningocele |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (4 listed)
- Patients over 18 years of age,
- Chronic inflammatory disease,
- Ongoing anti-inflammatory treatments,
- No parental consent,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSF sampling during surgeryProteomic 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. | Procedure or surgery | all patients who are to undergo surgery for tethered spinal cord |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSF sampling during surgery in people with Tethered Spinal Cord, Including Thickened Filum, Lipomas, Myelomeningocele and Meningocele, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.