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 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT02105935
Eligibility Criteria:
Inclusion Criteria:
* • Male and Female Athletes: Age 8-14 (Arm 1) or 8-18 years (Arm 2).
* For Arm 1 - Over 3 days and below 7 days post-concussion (sports-related) and currently symptomatic
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate and able to give informed assent (child) and Parental consent
Exclusion Criteria:
* Currently with lice or open wounds on scalp.
* Long and thick hair that prevents the proper administration of an EEG cap.
* Significant sensory deficits, e.g., deafness or blindness.
* Normative Exclusion Criteria:
* Any chronic disease as determined by clinical evaluation and medical history.
* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc. as determined by clinical evaluation and the Mini International Neuropsychiatric Interview (MINI)
* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc. as determined by clinical evaluation
* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc. as determined by clinical evaluation
* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
* Substance abuse in the last 3 months.
* History of any clinically significant brain trauma as determined by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT02105935
Study Brief:
Protocol Section:
NCT02105935