Indirect Intracranial Pressure Measurement in Patients With Concussion

Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

Description:

In this trial we are testing a medical monitoring device called the Headsense-1000 that may help diagnose and manage symptoms of a possible concussion in young athletes. A concussion or brain injury can increase the pressure in the skull and sometimes this pressure can cause serious medical problems.

During this trial we will use the HeadSense monitoring device, which uses an audio signal, to record pressure of fluid inside the skulls of patients with injuries or concussions as well as patients with no injuries or concussions. Comparing the results will allow to determine if the HeadSense device has value in diagnosing and treating young athletes with head injuries.


Who may qualify:

All patients 12 to 17 years of age with a history and/or symptoms of head trauma.

Who does not qualify:

Patients who:

Complete study information: https://clinicaltrials.gov/ct2/show/NCT02699359?term=headsense&rank=10

Medication Under Study:
HeadSense (HS-1000 recording device)

Study Sponsor(s):

HeadSense Medical

Full IRB Study Title:
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion

IRB Study ID:
141007

If you are interested in this study or have questions about your child's eligibility, please contact: Rebecca D. Considine Research Institute, 330-543-5012


Lead Principal Investigator:

Photo
Joseph Congeni, MD
Director, Sports Medicine; Clinical Co-Director, Center for Orthopedics and Sports Medicine


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