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 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT07210333
Eligibility Criteria:
Inclusion Criteria
Patients of both sexes.
Age ≥ 18 years.
Clinical signs and symptoms of traumatic brain injury (mild, moderate, or severe) or stroke (ischemic or hemorrhagic).
Signed informed consent form by the patient or by a legally authorized representative in cases where the patient is unable to consent due to the severity of the clinical condition. If the legal representative is not present at the time of admission or initial care, consent may be obtained retrospectively.
Exclusion Criteria
Individuals with brain lesions of other etiologies, such as previous TBI and/or stroke, neoplasms, infections, sepsis, arteriovenous malformation, intoxication, or illicit drug use.
Individuals with scalp or skin lacerations that prevent proper placement of the brain4care sensor.
Individuals with craniectomy or skull fractures.
Individuals with severe debilitating mental health disorders and/or severe debilitating neurological diseases.
Individuals who are agitated, aggressive, or uncooperative, preventing follow-up and outcome assessment.
Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07210333
Study Brief:
Protocol Section:
NCT07210333