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NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit (MINIPIC REA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01685476
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : July 8, 2014
Echodia SAS
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Traumatic Brain Injury Stroke Intracranial Hemorrhages Device: Echodia® hand-held equipment Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Validation of a New Non Invasive Method for Intracranial Pressure Monitoring
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Intracranial pressure Device: Echodia® hand-held equipment

Primary Outcome Measures :
  1. Cochlear Microphonic Potential phase shift [ Time Frame: acquisition every 5minutes during 4hours ]

Secondary Outcome Measures :
  1. IntraCranialPressure variations [ Time Frame: every minutes during 4 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with intracranial pressure monitoring
  • Age greater than 18
  • consent form signed by a close relative (husband, wife, children, legal guardian),
  • Patient covered under French social security or being a beneficiary of such a regime under the terms of the Act of August 9, 2004

Exclusion Criteria:

  • Refusal by the close relative to sign a consent form
  • Impossibility of electrophysiological measurements (pathophysiological reason)
  • Technical troubles with the device
  • Patient uncovered under French social security

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685476

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Chu Clermont Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Echodia SAS
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Principal Investigator: Laurent SAKKA University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand Identifier: NCT01685476    
Other Study ID Numbers: CHU-0124
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by University Hospital, Clermont-Ferrand:
Cochlear microphonic potential
non invasive method
indirect monitoring
intracranial pressure
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Intracranial Hemorrhages
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases