Status:
NOT_YET_RECRUITING
Identification of Sodium Channel Fragments as Serum Biomarkers of a Traumatic Central Nervous System Injury
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Spinal Cord Injury
Spasticity, Muscle
Eligibility:
All Genders
18-75 years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
- Exclusion criteria:
- 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:
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06532760
Start Date
October 1 2024
End Date
April 1 2027
Last Update
August 1 2024
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