Indirect Intracranial Pressure Measurement in Patients With Suspected or Documented Concussion
Status unconfirmed · Not applicable
Conditions studied: Brain Concussion, Brain Injuries
In brief
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.
Key facts
- Study ID
- NCT02699359
- Run by
- HeadSense Medical
- People needed
- 100
- Starts
- 2015-05-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2019-10-30
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Akron Children's Hospital — Akron, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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