NIMIP: Non Invasive Measurement of the Intracranial Pressure (MINIPIC)

September 11, 2012 updated by: University Hospital, Clermont-Ferrand

Validation of a New Non Invasive Method of Indirect Measurement of the Intracranial Pressure Variations

The intracranial pressure (ICP), defined by the hydrostatic pressure of the cerebrospinal fluid (CSF), is a key parameter for diagnosing and treating several neurosurgical diseases. Continuous ICP monitoring has an important place in neuro-intensive care for patients with severe head trauma and severe meningeal hemorrhage.

Until now the assessment of ICP requires invasive methods, with a pressure transducer either within the ventricular CSF or within the brain parenchyma. The pressure sensor placement is performed in a neurosurgery department. These invasive methods have also disadvantages: highest risk of infections, catheter misplaced, and risk of bleeding. All these justify the development of a non invasive method. The Biophysics Laboratory (School of Medicine of Clermont-Ferrand) described that the intra-labyrinthic pressure (ILP) modify the functional activities of the outer hair cells in the cochlea.

Cochlear activities' recording is non-invasive and technically simple. A probe is gently inserted into the outer portion of the external ear canal.

Anatomical studies showed communication between the subarachnoid spaces and the perilymphatic compartment by the cochlear aqueduct. Thereby, increases in ICP are transferred to increases in intra-cochlear pressure, which is detected as modifications in cochlear activities.

CSF dynamic tests, as constant flow infusion test, are conducted in patients in the diagnosis of the idiopathic adult hydrocephalus syndrome. Artificial CSF is infused through a lumbar needle, into the CSF space at a constant rate, and the corresponding rise in ICP is registered and analyzed.

The objective of this study is to assess prospectively the accuracy and the precision of a new method for non invasive ICP measurement (using cochlear activities) compared with invasive gold standard CSF pressure measurement during CSF dynamic tests.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Patients, from the neurosurgery department, investigated for 'normal pressure' chronic hydrocephalus are involved in CSF dynamic test. This complex protocol, including infusion test and invasive CSF monitoring, is needed in order to confirm the diagnosis. CSF dynamic tests, a socalled 'perfusion test', are performed in an operating theater, the patient had to be awake but sedated. During perfusion test, electrophysiological cochlear activities are measured with a gold tiptrode (Etymotic Research, Elk Grove Village, Ill) gently inserted into the ear canal.

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.

Previously animal studies have shown that the phase of CM is sensitive to ICP changes and CM phase shifts exhibit the same time course as those of otoacoustic emissions (DPOAEs).

The phase changes of CM can indeed be used as a non-invasive tool for monitoring intralabyrinthine and intracranial pressures.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with suspected chronic hydrocephalus, undergoing a CSF dynamic test (perfusion test)
  • Age greater than 18
  • Subject provides written informed consent, or 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 to sign a consent form

    • under otoscopy, presence of obstruction of the ear canal with wax (cerumen).
    • Impossibility of electrophysiological measurements (pathophysiological reason)
    • Technical troubles with the device
    • Patient uncovered under French social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intracranial pressure
Device: Echodia® hand-held equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cochlear Microphonic Potential
Time Frame: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)
acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)

Secondary Outcome Measures

Outcome Measure
Time Frame
IntraCranialPressure Variations
Time Frame: every minutes during CerebroSpinal Fluid dynamic test time (30-45min)
every minutes during CerebroSpinal Fluid dynamic test time (30-45min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Echodia SAS

Investigators

  • Principal Investigator: Laurent SAKKA, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

August 31, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU 0123
  • 2010-A00266-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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