Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
|ClinicalTrials.gov Identifier: NCT01863381|
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : May 29, 2013
Last Update Posted : August 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus Idiopathic Intracranial Hypertension Pseudotumor Cerebri||Device: Tympanic membrane displacement (TMD) Device: DPOAE||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement: Continuous Intracranial Pressure Monitoring Subprotocol|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||October 2015|
Patients between the ages of 18-65 years with suspected hydrocephalus or idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri, who are recommended by their doctor based on standard clinical criteria to undergo intracranial pressure monitoring. The interventions include tympanic membrane displacement (TMD) and DPOAE.
Device: Tympanic membrane displacement (TMD)
The CCFP Analyser has a passive mode and an active mode. When used in active mode, the device generates a tone burst that is transmitted to the ear to elicit contraction of the stapedius muscle. The passive mode requires no stimulus or sound burst.
For the lying, sitting, standing, and 10-degree head-down tilt conditions, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration.
Overnight recording of non-invasive ICP will be done using the passive mode of the CCFP device.
Other Names:Device: DPOAE
DPOAE measurement uses a clinical acoustic probe to record the ear's response to two simultaneous tones. DPOAE measurements will be made for 13 tones. The total measurement time for each condition is 2-4 minutes.
Other Name: Distortion Product Otoacoustic Emissions
- Noninvasive ICP [ Time Frame: Day 1 (Concurrent with invasive ICP monitoring) ]Bland-Altman analysis: the difference between the noninvasive ICP and the invasive ICP is plotted against the mean of both the noninvasive and invasive ICP at each ICP level
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863381
|United States, Maryland|
|Sinai Hospital of Baltimore|
|Baltimore, Maryland, United States, 21209|
|Principal Investigator:||Michael A. Williams, MD||LifeBridge Health|