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NIMI-NICU: Non Invasive Monitoring of the Intracranial Pressure - NeuroIntensive Care Unit

Validation of a New Non Invasive Method for Intracranial Pressure Monitoring

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01685476
Acronym
MINIPIC REA
Enrollment
20
Registered
2012-09-14
Start date
2011-01-01
Completion date
2012-11-01
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hemorrhages, Intracranial Pressure, Stroke, Traumatic Brain Injury

Keywords

Cochlear microphonic potential, non invasive method, indirect monitoring, intracranial pressure

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.

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.

Interventions

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
Echodia SAS
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Cochlear Microphonic Potential phase shiftacquisition every 5minutes during 4hours

Secondary

MeasureTime frame
IntraCranialPressure variationsevery minutes during 4 hours

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLaurent SAKKA

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026