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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT02688660
Eligibility Criteria:
Inclusion Criteria:
Aim 1 Subjects:
* Children 0 through \< 18 years of age
* Diagnosis of severe TBI (defined as a Glasgow Coma Scale (GCS) score less than or equal to 8)
* Had an intracranial pressure (ICP) monitor as part of standard care
Aims 2 \& 3 Subjects:
* Children 9 through \< 18 years of age with severe TBI
* Consent for a follow-up MRI within 10 years of the time of TBI
Controls:
* Healthy children greater than or equal to 9 and \< 18 years of age.
Exclusion Criteria:
* TBI \& controls:
* Anyone unable to tolerate a non-sedated MRI
Controls:
* Any history of head injury resulting in loss of consciousness
* Standard contraindications to MRI (metallic implants, implanted electronic devices, pregnancy, etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT02688660
Study Brief:
Protocol Section:
NCT02688660