Spinal Cord InjurySpasT-SCI-TNCT06532760
Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury
A study testing Blood sampling in people with Spinal Cord Injury and Spasticity, Muscle, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Spasticity, Muscle, Brain Injuries
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 75
- Beneficiary of or affiliated to a social security scheme
- Having suffered within 6 hours a trauma with an acute LME confirmed according to the following characteristics:
- Lesion located at C4-T12 level and radiologically documented (CT scan and/or spinal MRI performed within 6 hours)
- Complete or incomplete according to the American Spinal Injury Association impairment scale (ASIA A to D)
- Signed consent for emergency and continuation of study
Show all 14Show fewer
- Male or female
- Aged 18 to 75
- Have suffered a traumatic brain injury (TBI) with a proven acute brain injury according to the following characteristics:
- Glasgow score less than 13 on admission without metabolic cause in the context of head trauma
- Cerebral CT scan at least grade II according to Marshall classification
- Absence of traumatic spinal lesion threatening the integrity of the spinal canal assessed by neuroradiological examination (CT and/or MRI)
- Signed consent for emergency and continuation of study
- ASIA E score
Who cannot join
- Pregnant or breast-feeding women
- Person under guardianship or curatorship
- Diagnosis of a neurological disorder
- Diagnosis of a psychiatric disorder
- Diagnosis of a neurodegenerative disease
- Spinal Cord injury patients group:
Show all 17Show fewer
- Pregnant or breast-feeding patient
- Absence of consent from the volunteer or his/her trusted support person
- Patient under guardianship or trusteeship
- Brain injury due to cranioencephalic trauma with a Glasgow score of less than 14 on reassessment, associated with a cerebral CT scan of grade III or less on the Marshall classification
- Presence of another neurological or mental disorder or neurodegenerative disease
- Brain injury patients Group:
- Pregnant or breast-feeding patient
- Absence of consent from the volunteer or his/her trusted support person
- Patient under guardianship
- ASIA score A to D
- Presence of another neurological or mental disorder or neurodegenerative disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Identification Des Fragments de Canaux Sodiques Comme Biomarqueurs sériques d'Une lésion Traumatique du système Nerveux Central
Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting the medium and long-term clinical course in terms of emergence and severity of spasticity and neurological recovery. Recently, pre-clinical models in rats have shown the presence of protein fragments from a cleavage of sodium channels in spinal cords below the level of injury. Other studies have also shown the presence of these fragments in the brain following a head injury. These fragments would be potentially useful as a biomarker of the SCI. The detection of sodium fragments would be potentially useful as a biomarker of a lesion of the central nervous system (spinal cord or brain) and of the severity of the spasticity in patients suffering from SCI. The main objective of this study is to detect the presence of sodium fragments in blood samples from patients with SCI from or brain injury. The secondary objectives will be to study the post-lesional / injury kinetics of sodium fragments, to determine their diagnostic values in terms of the severity of the injury, and their prognostic values concerning the emergence of the spasticity in patients with SCI. An initial prospective cohort will include 40 people. The fragments of sodium channels will be measured in blood samples taken within 6 hours post-trauma, then 1, 3, 5 and 7 days post-trauma, as well as 3 and 6 months post-trauma. The overall expression of sodium fragments will be compared to that of healthy controls. Participants will be recruited in the acute care units of the AP-HM. Participants will be recruited from the main acute care units of the AP-HM. Post-traumatic follow-up assessments during their rehabilitation will be carried out at 3 and 6 months in the neurosurgery department of North Hospital from APHM.
- Conditions
- Spinal Cord Injury, Spasticity, Muscle, Brain Injuries
- Being tested
- Blood sampling
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling to study sodium fragment kinetics
| Study group | Role | What they receive |
|---|---|---|
| Patients with Spinal cord injury | Experimental | Not described Receives: Other: Blood sampling |
| Patients with Brain Injury | Active comparator | Not described Receives: Other: Blood sampling |
| Healthy volunteers | Active comparator | Not described Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the presence of sodium fragments in blood samples from patients
Measured: 6 hours to 6 months post-injury
Secondary outcomes (2)
kinetics of sodium fragments in patients with acute SCI and in traumatic brain injury patients in the post-trauma period
Measured: 6 hours to 6 months post-injury
To correlate measurements of sodium fragments in blood from 6 hours to 6 months post-injury with the occurence of spasticity in the post-trauma period
Measured: 3 and 6 months-post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, francois.cremieux@ap-hm.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532760
- Sponsor's protocol ID
- RCAPHM21_0427
- Acronym
- SpasT-SCI-T
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baucher G, Liabeuf S, Brocard C, Ponz A, Baumstarck K, Troude L, Leone M, Roche PH, Brocard F. The SpasT-SCI-T trial protocol: Investigating calpain-mediated sodium channel fragments as biomarkers for traumatic CNS injuries and spasticity prediction. PLoS One. 2025 May 21;20(5):e0319635. doi: 10.1371/journal.pone.0319635. eCollection 2025.
PubMed 40397864
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Des Fragments de Canaux Sodiques Comme Biomarqueurs sériques d'Une lésion Traumatique du système Nerveux Central
- ClinicalTrials.gov ID
- NCT06532760
- Acronym / sponsor ID
- SpasT-SCI-T / RCAPHM21_0427
- Conditions
- Spinal Cord Injury, Spasticity, Muscle, Brain Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Aug 2024 (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.
Following spinal cord injury (SCI), 75% of patients develop spasticity of the limbs characterized by an increase in muscle tone causing severe pain. Currently, the diagnosis of spinal cord injury is based on clinical and radiological evaluation by CT and MRI, but there is no reliable biomarker capable of predicting the medium and long-term clinical course in terms of emergence and severity of spasticity and neurological recovery. Recently, pre-clinical models in rats have shown the presence of protein fragments from a cleavage of sodium channels in spinal cords below the level of injury. Other studies have also shown the presence of these fragments in the brain following a head injury. These fragments would be potentially useful as a biomarker of the SCI. The detection of sodium fragments would be potentially useful as a biomarker of a lesion of the central nervous system (spinal cord or brain) and of the severity of the spasticity in patients suffering from SCI. The main objective of this study is to detect the presence of sodium fragments in blood samples from patients with SCI from or brain injury. The secondary objectives will be to study the post-lesional / injury kinetics of sodium fragments, to determine their diagnostic values in terms of the severity of the injury, and their prognostic values concerning the emergence of the spasticity in patients with SCI. An initial prospective cohort will include 40 people. The fragments of sodium channels will be measured in blood samples taken within 6 hours post-trauma, then 1, 3, 5 and 7 days post-trauma, as well as 3 and 6 months post-trauma. The overall expression of sodium fragments will be compared to that of healthy controls. Participants will be recruited in the acute care units of the AP-HM. Participants will be recruited from the main acute care units of the AP-HM. Post-traumatic follow-up assessments during their rehabilitation will be carried out at 3 and 6 months in the neurosurgery department of North Hospital from APHM.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 groups
| Arm | Type | Receives |
|---|---|---|
| Patients with Spinal cord injury | Experimental | Other: Blood sampling |
| Patients with Brain Injury | Active comparator | Other: Blood sampling |
| Healthy volunteers | Active comparator | Other: Blood sampling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 18 to 75
- Beneficiary of or affiliated to a social security scheme
- Having suffered within 6 hours a trauma with an acute LME confirmed according to the following characteristics:
- Lesion located at C4-T12 level and radiologically documented (CT scan and/or spinal MRI performed within 6 hours)
- Complete or incomplete according to the American Spinal Injury Association impairment scale (ASIA A to D)
Key exclusion criteria (17 listed)
- Pregnant or breast-feeding women
- Person under guardianship or curatorship
- Diagnosis of a neurological disorder
- Diagnosis of a psychiatric disorder
- Diagnosis of a neurodegenerative disease
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 |
|---|---|---|
| Blood samplingBlood sampling to study sodium fragment kinetics | Other | Healthy volunteers, Patients with Brain Injury, Patients with Spinal cord injury |
Primary outcome
Detect the presence of sodium fragments in blood samples from patients
Time frame: 6 hours to 6 months post-injury
2 secondary outcomes
kinetics of sodium fragments in patients with acute SCI and in traumatic brain injury patients in the post-trauma period
Time frame: 6 hours to 6 months post-injury
To correlate measurements of sodium fragments in blood from 6 hours to 6 months post-injury with the occurence of spasticity in the post-trauma period
Time frame: 3 and 6 months-post-injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40397864Baucher G, Liabeuf S, Brocard C, Ponz A, Baumstarck K, Troude L, Leone M, Roche PH, Brocard F. The SpasT-SCI-T trial protocol: Investigating calpain-mediated sodium channel fragments as biomarkers for traumatic CNS injuries and spasticity prediction. PLoS One. 2025 May 21;20(5):e0319635. doi: 10.1371/journal.pone.0319635. eCollection 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
François CREMIEUX study director
francois.cremieux@ap-hm.fr
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Spinal Cord Injury and Spasticity, Muscle, run by Assistance Publique Hopitaux De Marseille.
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 14 inclusion and 17 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: opening soon, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Hugues ROCHE (0033491365135, Pierre-hugues.ROCHE@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the presence of sodium fragments in blood samples from patients (time frame: 6 hours to 6 months post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06532760, which also lists 1 linked publication.
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 1 Aug 2024.