NCT01685450

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

2.3 years

First QC Date

August 31, 2012

Last Update Submit

September 11, 2012

Conditions

Chronic Hydrocephalus

Keywords

Cochlear microphonic potentialnon invasive methodindirect measurementintracranial pressureadults

Outcome Measures

Primary Outcomes (1)

  • Cochlear Microphonic Potential

    acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)

Secondary Outcomes (1)

  • IntraCranialPressure Variations

    every minutes during CerebroSpinal Fluid dynamic test time (30-45min)

Study Arms (1)

Intracranial pressure

OTHER
Device: Echodia® hand-held equipment

Interventions

Echodia® hand-held equipmentDEVICE
Intracranial pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Study Officials

  • Laurent SAKKA

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 14, 2012

Study Start

June 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

FR(1)