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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT02699359
Eligibility Criteria:
Inclusion Criteria:
* All patients 12 to \< 18 years of age being seen for, diagnosed with, and/or treated for traumatic brain injury (TBI) at the Akron Children's Hospital Sports Medicine Concussion Clinic are eligible for enrollment in this study.
* The control group will consist of demographically comparable patients being treated at the Akron Children's Hospital Sports Medicine Center unrelated to head trauma. These non-brain injured study participants will receive the same ICP monitoring device measurements at their initial examination and follow-up visits as performed in concussed patients.
Exclusion Criteria:
* Receiving therapy for otitis media
* Subject with bony abnormality of the skull secondary to previous fracture or other cause that may impede HeadSense device
* Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
* For females of childbearing potential: pregnancy (positive pregnancy test)
* Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
* Any condition that may jeopardize study participation or interpretation of study results (e.g., abnormal clinical finding), or may impede the ability to obtain informed consent (e.g., developmental delay of patient or caretaker)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT02699359
Study Brief:
Protocol Section:
NCT02699359