Hydrocephalus Clinical Trial
Official title:
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP).
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 cerebrospinal fluid (CSF) infusion testing.
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, shunt malfunction, or other disorders of CSF circulation who have
been recommended on the basis of standard clinical criteria to have CSF infusion testing are
eligible.
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