NIMIP: Non Invasive Measurement of the Intracranial Pressure

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Brief Title

NIMIP: Non Invasive Measurement of the Intracranial Pressure

Official Title

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

Brief Summary

      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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

Cochlear Microphonic Potential

Secondary Outcome

 IntraCranialPressure Variations

Condition

Chronic Hydrocephalus

Intervention

Echodia® hand-held equipment

Study Arms / Comparison Groups

 Intracranial pressure
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

25

Start Date

June 2010

Completion Date

September 2012

Primary Completion Date

September 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Laurent SAKKA, 04 73 75 11 95, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01685450

Organization ID

CHU 0123

Secondary IDs

2010-A00266-33

Responsible Party

Sponsor

Study Sponsor

University Hospital, Clermont-Ferrand

Collaborators

 Echodia SAS

Study Sponsor

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


Verification Date

September 2012