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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT02354469
Eligibility Criteria:
Inclusion Criteria:
1. Participation on a Harvard University varsity athletic team
2. Medically cleared to participate in sport, as determined by Harvard medical staff
3. Diagnosed with concussion by Harvard medical staff, and agreement to participate in the post-injury component of the study within five days of injury (post-concussion group)
4. No diagnosed concussion within the previous year of evaluation (control group)
Exclusion Criteria:
1. A history of epilepsy, prior seizure, or any previous abnormal EEG finding or abnormal brain imaging (CT or MRI) finding, as reported by the patient.
2. Any pre-existing neurological disorder, including but not limited to stroke, intracranial hemorrhage, any movement disorder, and cerebral palsy.
3. Any currently active psychiatric condition, including specifically major depression, bipolar disorder or schizophrenia. A history of a psychiatric condition but no ongoing psychiatric episode (e.g. not currently undergoing treatment for a major depressive episode) would not be an exclusion.
4. Any unstable medical condition
5. For the transcranial Doppler ultrasound component of the study only, subjects with infection, history of seizure, cardioactive drug participation, presence of deep vein thrombosis, cervical injury (structural or vascular), gross motor deficits, or skull fractures will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT02354469
Study Brief:
Protocol Section:
NCT02354469