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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT02661633
Eligibility Criteria:
Inclusion Criteria:
* Concussion-Injury subjects will be defined as follows: Any player who, based on independent clinical impression, is suspected of having suffered a concussion of any severity level, and on whom a routine clinical examination for concussion or head injury would have been conducted prior to implementation of this research protocol according to current standard practice.
1. If loss of consciousness, total duration less than \<20 minutes
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. Do not speak or read English
2. Current CNS active prescription medications, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD)
3. Skull abnormalities, e.g. metal plate
4. History of brain surgery or neurological disease
5. Pregnant women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
19 Years
Study:
NCT02661633
Study Brief:
Protocol Section:
NCT02661633