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

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ClinicalTrials.gov Identifier: NCT01685450
Recruitment Status : Unknown
Verified September 2012 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : September 14, 2012
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
Echodia SAS
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 14, 2012
Last Update Posted Date September 14, 2012
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
Cochlear Microphonic Potential [ Time Frame: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
IntraCranialPressure Variations [ Time Frame: every minutes during CerebroSpinal Fluid dynamic test time (30-45min) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NIMIP: Non Invasive Measurement of the Intracranial Pressure
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Condition  ICMJE Chronic Hydrocephalus
Intervention  ICMJE Device: Echodia® hand-held equipment
Study Arms  ICMJE Intracranial pressure
Intervention: Device: Echodia® hand-held equipment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2012)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685450
Other Study ID Numbers  ICMJE CHU 0123
2010-A00266-33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Echodia SAS
Investigators  ICMJE
Principal Investigator: Laurent SAKKA University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP