Brain Injuries, Spasticity, Muscle, Spinal Cord Injury
Conditions
Brief 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 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.
Interventions
OTHERBlood sampling
Blood sampling to study sodium fragment kinetics
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
3 groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
healthy volonteers group: Inclusion Criteria * Male or Female * Age 18 to 75 * free of central or peripheral nervous system trauma * Having given free and informed consent * Beneficiary of or affiliated to a social security scheme
Exclusion criteria
* 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: Inclusion Criteria:- Male or female * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detect the presence of sodium fragments in blood samples from patients | 6 hours to 6 months post-injury |
Secondary
| Measure | 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 | 3 and 6 months-post-injury |
Contacts
Primary ContactPierre-Hugues ROCHE
Outcome results
None listed