Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant or breast-feeding women

Person under guardianship or curatorship

Diagnosis of a neurological disorder

Diagnosis of a psychiatric disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Other intervention

    Blood sampling to study sodium fragment kinetics

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Patients with Spinal cord injuryExperimental treatment 1 intervention
Group B: Patients with Brain InjuryActive comparator 1 intervention
Group C: Healthy volunteersActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Detect the presence of sodium fragments in blood samples from patients

Time frame
6 hours to 6 months post-injury

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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