Validation of Non-Invasive Intracranial Pressure (ICP) Monitoring Device

Status unconfirmed

Conditions studied: Intracranial Hypertension, Abnormality of Intracranial Pressure

In brief

For purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (ICP) device, with the values obtained from (a) patients in an intensive care unit (ICU) whose meet standard clinical indications for ICP measurement and whose ICP is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.

Key facts

Study ID

NCT03865576

Run by

Boston Neurosciences

People needed

80

Starts

2019-03-01

Expected to finish

2019-10-31

Last updated by the study team

2019-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ICU patients suspected of having an abnormality of ICP undergoing monitoring with commercially-available, FDA-approved instrumentation.

You may not qualify if…

• History of:
• Glaucoma or optic hypertension
• Severe orbital or ophthalmic injury
• Orbital or intraocular surgery that might interfere with orbital compliance
• Congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy

Where it is running

• Honor Health Research Institute — Phoenix, Arizona, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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