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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02783105
Eligibility Criteria:
Inclusion Criteria:
* Severe traumatic brain injury (either initial Glasgow Coma Scale \< 8 or intracranial pressure \> 20mmHg for more than 20 min)
* National health service coverage
* Informed consent signed by next of kin
Exclusion Criteria:
* Non-traumatic brain injury
* Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis,
* Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation
* Respiratory rate \< 9/min
* Patient subject to guardianship or wardship
* Pregnant or breastfeeding woman
* Current participation in another biomedical research protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02783105
Study Brief:
Protocol Section:
NCT02783105