Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement

NATerminatedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

August 31, 2015

Study Completion Date

October 31, 2015

Conditions
HydrocephalusIdiopathic Intracranial HypertensionPseudotumor Cerebri
Interventions
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."

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.

Trial Locations (1)

21209

Sinai Hospital of Baltimore, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LifeBridge Health

OTHER

NCT01863381 - Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement | Biotech Hunter | Biotech Hunter