Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT06532760
Eligibility 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
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06532760
Study Brief:
Protocol Section:
NCT06532760