Chronic Hydrocephalus Clinical Trial
— MINIPICOfficial title:
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.
| Status | Recruiting |
| Enrollment | 25 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Clermont Ferrand | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Echodia SAS |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cochlear Microphonic Potential | acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min) | Yes | |
| Secondary | IntraCranialPressure Variations | every minutes during CerebroSpinal Fluid dynamic test time (30-45min) | Yes |