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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (ICP) device based on trans-cranial Doppler technology. The ophthalmic artery is utilized as a natural ICP sensor. Up to 80 subjects will be recruited in 4 centers to achieve a power of 90% and a p<0.05 compared to the values obtained from (a) patients in an 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. At least two comparative readings, separated by an hour or more, will be obtained from each subject. ;

Study Design

Related Conditions & MeSH terms

Abnormality of Intracranial Pressure
Intracranial Hypertension

Clinical Trial Details

NCT number	NCT03865576
Study type	Observational
Source	Boston Neurosciences
Contact
Status	Active, not recruiting
Phase
Start date	March 1, 2019
Completion date	October 31, 2019

View Details

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