Stroke Clinical Trial
Official title:
Validation of a New Non Invasive Method for Intracranial Pressure Monitoring
In clinical practice, intracranial pressure (ICP) represents a key parameter for diagnosing
and treating several conditions. Physicians having to manage cases of head trauma, stroke
and hydrocephalus need to assess the time course of ICP, yet they are often unwilling to
implement invasive monitoring beyond the acute stage, on account of high septic risks.
Standard techniques include direct ventricular manometry or measurement in the parenchyma
with electronic or fiberoptic devices. Therefore, the design of non-invasive clinical
methods for gaining access to pressure changes is an important challenge. Fluctuations of
ICP are transmitted to the fluid spaces of the inner ear through the cochlear aqueduct. The
Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the
intra-labyrinthic pressure modify the functional activities of the outer hair cells in the
cochlea. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure,
which is detected as modifications in cochlear activities. Cochlear activities' recording
are non-invasive and technically simple. A probe is gently inserted into the outer portion
of the external ear canal.
The objective of this study is to assess prospectively the accuracy and the precision of a
new method for ICP monitoring (using cochlear activities) compared with invasive gold
standard CSF pressure monitoring.
The purpose of this study is to examine the evolution of the electrophysiological cochlear
activity (cochlear microphonic potential, CMP), with a non invasive method, during invasive
ICP monitoring. The data analysis will determine relationship between ICP variations and CMP
variations.
Continuous ICP monitoring has an important place in neuro-intensive care. ICP may be
measured either within the ventricular cerebrospinal fluid or within the brain parenchyma.
The purpose of this study is to assess prospectively the accuracy and the precision of a new
method for indirect ICP monitoring (using electrophysiological cochlear activity) compared
with an invasive gold standard ICP monitoring. The data analysis will determine relationship
between ICP variations and CMP variations.
Electrophysiological cochlear activities, so called electrocochleography (ECochG), are a non
invasive and totally passive method used in routine in ENT department. The response measured
in ECochG is the cochlear microphonic potential (CMP), generated by the outer hair cells
following by presenting tone burst at 1kHz. CMP is recorded with the help of an Echodia®
hand-held equipment.
Technically, a simple, non-invasive detection of ICP changes and ICP monitoring can be
afforded by CMP recordings.
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Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
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