Comparison of Continuous Non-Invasive & Invasive Intracranial Pressure

Status Terminated

Clinical Trial Summary

This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.

Clinical Trial Description

Recently, astronauts in long-duration spaceflight have been found to have a syndrome consisting of swelling of the optic nerve, impaired vision, and elevated cerebrospinal fluid pressure (also known as intracranial pressure [ICP]) via lumbar puncture (LP), which is similar to the syndrome of idiopathic intracranial hypertension (IIH). In astronauts, this syndrome is called Visual Impairment/Intracranial Pressure (VIIP). It is not possible to perform an LP on astronauts in space. Noninvasive methods of estimating ICP exist but have not been tested against continuous ICP methods in a patient cohort that is physiologically similar to that of astronauts.

The primary objective of this study is to determine the validity, reliability, accuracy, and precision of two noninvasive methods of ICP measurement (tympanic membrane displacement (TMD, Marchbanks Measurements Systems, UK) and distortion product otoacoustic emissions (DPOAE) in comparison to a reference standard, invasive ICP measurement, in human subjects undergoing diagnostic ICP monitoring.

The two noninvasive methods are based on the responses of the inner ear and middle ear to changes in ICP. The first method is TMD, which measures tiny movements of the ear drum, and the second is DPOAE, which is routinely used for newborn hearing screening.

Adults with hydrocephalus or pseudotumor cerebri who have been recommended on the basis of standard clinical criteria to have ICP monitoring either by insertion of a temporary spinal catheter or by insertion of a needle into an existing shunt reservoir are eligible.

After insertion of the spinal catheter or the needle in the shunt, subjects will undergo testing with the TMD and DPOAE in the lying, sitting, standing, and head-down tilt (10 degrees) position. In addition, testing will be performed during sleep, when normal fluctuations of ICP occur.

Diagnostic decisions will be based on the standard invasive ICP monitoring only, and not based on the noninvasive ICP monitoring. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01863381
Study type	Interventional
Source	LifeBridge Health
Contact
Status	Terminated
Phase	N/A
Start date	September 2014
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06040697` - Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Terminated	`NCT02408757` - Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
Completed	`NCT00652470` - A Study Comparing Two Treatments for Infants With Hydrocephalus	Phase 2
Completed	`NCT00196196` - A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.	Phase 3
Terminated	`NCT05501002` - Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus	N/A
Active, not recruiting	`NCT05068128` - Combined Flow and Pressure Study of Craniospinal Dynamic
Completed	`NCT04496414` - Bactiseal Catheter Safety Registry in China
Terminated	`NCT02900222` - Study of Choroid Plexus Cauterization in Patients With Hydrocephalus	N/A
Recruiting	`NCT04099823` - MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics	N/A
Unknown status	`NCT02775136` - An Evaluation of a Non-invasive Brain Monitor	N/A
Completed	`NCT00692744` - Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)	N/A
Recruiting	`NCT04758611` - The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)	N/A
Completed	`NCT03595033` - Hydrocephalus iPad-App Based Intervention Study	N/A
Completed	`NCT04207229` - CERTAS Programmable Valve Registry
Completed	`NCT01976559` - Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol	N/A
Terminated	`NCT01973764` - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System	N/A
Completed	`NCT02381977` - Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment	N/A
Recruiting	`NCT06086561` - Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device	N/A
Recruiting	`NCT05910944` - European Study of Prodromal iNPH
Recruiting	`NCT03650101` - Improving Infant Hydrocephalus Outcomes in Uganda

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms