NCT03865576

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Boston Neurosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Hypertension
• Abnormality of Intracranial Pressure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-10-31
• Completion: 2019-10-31
• First posted: 2019-03-07
• Last updated: 2019-03-07

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study