Chronic HydrocephalusPhase 4MINIPICNCT01685450
NIMIP: Non Invasive Measurement of the Intracranial Pressure
A Phase 4 study testing Echodia® hand-held equipment in people with Chronic Hydrocephalus, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hydrocephalus
- What is being tested?
- Echodia® hand-held equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontefrrand.fr
About this study
Official 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Hydrocephalus
- Being tested
- Echodia® hand-held equipment
- Keywords
- Cochlear microphonic potential, non invasive method, indirect measurement, intracranial pressure, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echodia® hand-held equipmentDevice
| Study group | Role | What they receive |
|---|---|---|
| Intracranial pressure | Other | Not described Receives: Device: Echodia® hand-held equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochlear Microphonic Potential
Measured: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)
Secondary outcomes (1)
IntraCranialPressure Variations
Measured: every minutes during CerebroSpinal Fluid dynamic test time (30-45min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startJun 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HydrocephalusStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Echodia SAS
- Responsible party
- Sponsor
- Investigators
- Laurent SAKKA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685450
- Sponsor's protocol ID
- CHU 0123
- Other IDs
- 2010-A00266-33
- Acronym
- MINIPIC
- Status last verified
- Sep 2012
- First submitted
- 31 Aug 2012
- Last updated
- 14 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Non Invasive Method of Indirect Measurement of the Intracranial Pressure Variations
- ClinicalTrials.gov ID
- NCT01685450
- Acronym / sponsor ID
- MINIPIC / CHU 0123
- Conditions
- Chronic Hydrocephalus
- Keywords
- Cochlear microphonic potential, non invasive method, indirect measurement, intracranial pressure, adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Echodia SAS
- Study start
- Jun 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial pressure | Other | Device: Echodia® hand-held equipment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- refusal to sign a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echodia® hand-held equipment | Device | Intracranial pressure |
Primary outcome
Cochlear Microphonic Potential
Time frame: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)
1 secondary outcome
IntraCranialPressure Variations
Time frame: every minutes during CerebroSpinal Fluid dynamic test time (30-45min)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent SAKKA principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echodia® hand-held equipment in people with Chronic Hydrocephalus, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochlear Microphonic Potential (time frame: acquisition every minutes during "Cerebrospinal Fluid Dynamic Test time(30-45min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.