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:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-24 @ 1:09 PM
NCT ID:
NCT02957461
Eligibility Criteria:
Inclusion Criteria (For Injured Subjects):
1. Time of injury within 72 hours of BrainScope Battery
2. No evidence of abnormality visible on Computerized Tomography (CT) of the head related to the traumatic event (Note: neuroimaging is not required for enrollment)
3. No hospital admission due to either head injury or collateral injuries for \>24 hours
4. GCS between 13-15
Exclusion Criteria:
1. Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
2. Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD)
3. Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
4. History of brain surgery or neurological disease
5. Pregnant women
6. Do not speak or read English
7. Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
8. Prior history of concussion in the last year - for Matched Control subjects only
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT02957461
Study Brief:
Protocol Section:
NCT02957461