Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

Unlike fractures, concussion can be difficult to recognize and diagnose, given lack of
specific diagnostic tests or clinical findings. Current diagnostic recommendations include a
multi-factorial approach involving symptom inventory, baseline and post-injury
neuropsychological assessment, and balance testing.

Lacking from this paradigm is a truly objective measure of physiological changes associated
with concussion. In addition, post-concussion symptoms are unique to each individual and
vary in occurrence, degree, and severity. For these reasons, a clinical diagnosis of
concussion should be made by a healthcare provider familiar with the athlete and
knowledgeable in concussion symptom recognition and evaluation.

This study aims to determine ICP measurements derived from the HS-1000 non-invasive device
in children and adolescents seen in the Akron Children's Hospital Sports Medicine Clinic for
concussion (anytime during their care) compared to ICP values obtained in age and gender
matched Akron Children's Hospital Sports Medicine Clinic patients with no history of head
injury.

Patients with a history and/or symptoms of head trauma cared for in the Akron Children's
Hospital Sports Medicine Clinic will be invited to participate in this study. Study
participants will receive HS-1000 ICP readings for a continuous 16 minute interval in a 30
degree supine position. Recordings will be obtained in one session. When possible, these
recordings will be obtained at their initial examination and all follow-up visits. Sports
Medicine staff will coordinate the HS-1000 device earplug insertion and recordings so as not
to interfere with, nor marginally delay the patient's normal, routine clinical evaluation.

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)