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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Spinal cord injury | Experimental |
| |
| Patients with Brain Injury | Active Comparator |
| |
| Healthy volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Blood sampling to study sodium fragment kinetics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detect the presence of sodium fragments in blood samples from patients | 6 hours to 6 months post-injury |
| Measure | Description | Time Frame |
|---|---|---|
| kinetics of sodium fragments in patients with acute SCI and in traumatic brain injury patients in the post-trauma period | 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 |
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healthy volonteers group: Inclusion Criteria
Exclusion Criteria:
Spinal Cord injury patients group:
Inclusion Criteria:- Male or female
Exclusion criteria:
Brain injury patients Group:
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Hugues ROCHE | Contact | 0033491365135 | Pierre-hugues.ROCHE@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | francois.cremieux@ap-hm.fr | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40397864 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009128 | Muscle Spasticity |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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3 groups
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| 3 and 6 months-post-injury |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |