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

Intracranial Hypertension Clinical Trial

Official title:

Validation of a Non-Invasive Intracranial Pressure (ICP) Device by Comparison With Implanted Intracranial Pressure Monitoring Instrumentation or Lumbar Puncture

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03865576
• Other study ID #: nICP-1
• Status: Active, not recruiting
• Start date: March 1, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: March 2019
• Source: Boston Neurosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Abnormality of Intracranial Pressure
• Intracranial Hypertension

Intervention

Diagnostic Test:
• Non-invasive ICP measurement
Intracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania
United States	Honor Health Research Institute	Phoenix	Arizona
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Neurosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-invasive intracranial pressure (ICP) value	ICP value measured using novel non-invasive measurement device	Up to 5 days after admission to ICU
Primary	Second non-invasive intracranial pressure (ICP) value	A second measurement of ICP using novel non-invasive ICP measurement device	Up to 6 days after admission to ICU