Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Full IRB Study Title:
Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
IRB Study ID: 141007
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.
Study Sponsor:
HeadSense Medical
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:
- Are receiving therapy for otitis media
- Have any bony abnormality of the skull secondary to previous fracture or other cause that may impede HeadSense device
- Have known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- Are pregnant
- Are currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
- Have 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)
Complete study information: https://clinicaltrials.gov/ct2/show/NCT02699359?term=headsense&rank=10
Lead Investigator
Joseph Congeni, MD
Physician Liaison for Philanthropy; The Scala Family Endowed Chair in Sports Medicine
