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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT05201833
Eligibility Criteria:
Inclusion Criteria:
* LONGITUDINAL Telephone Assessment:
* Participated in TRACK-TBI,
* At least two years post injury, and
* Completed at least 1 GOSE during the TRACK-TBI follow-up assessments
* LONGITUDINAL BIOMARKER In-Person Assessment:
Must complete at least one Longitudinal Telephone Assessment and fall into one of the following groups:
* Group 1- Completed TRACK-TBI 6M MRI and are stable or improved with regard to Criteria for Establishing Decline
* Group 2- Criteria for Establishing Decline met when comparing the Telephone Assessments to the last completed TRACK-TBI assessment
* Group 3- All TRACK-TBI orthopedic controls
Ability of participant or legally authorized representative to provide informed consent
Exclusion Criteria:
* Dementia diagnosed prior to the index TBI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05201833
Study Brief:
Protocol Section:
NCT05201833