Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532760
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification Des Fragments de Canaux Sodiques Comme Biomarqueurs sériques dUne lésion Traumatique du système Nerveux Central
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SpasT-SCI-T
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None