Brain Injuries Clinical Trial
Official title:
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
The HS-1000 is an innovative non-invasive monitoring device that employs advanced acoustic signal analysis to calculate ICP on a continuous basis. Initial HS-1000 clinical data also shows promise in assessing a variety of cerebral hemodynamic parameters such as cerebral blood-flow, auto regulation monitoring, and cerebrovascular vessels compliance. In the absence of a non-invasive monitor of intracranial pressure (ICP), the relationships, if any, that may exist between concussion, timing of the concussion (e.g. acute, resolving, resolved) and ICP is unknown. The new HS-1000 non-invasive device may provide insight into assessment of possible ICP changes following concussion in children.
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.
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