Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage (HEMAPIC)
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ClinicalTrials.gov Identifier: NCT03040284 |
Recruitment Status : Unknown
Verified January 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
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In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.
A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.
The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with a standard imaging method (TDM).
The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes patient clinical worsening and / or imaging.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aneurysmal Subarachnoid Hemorrhage, Familial | Device: Echodia® hand-held equipment (ELIOS) | Not Applicable |
In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.
A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.
The evaluation of intracranial hypertension by increased ICP (invasive) is not systematically used after aneurysmal subarachnoid hemorrhage. It is then detected by using routine clinical signs of hydrocephalus or another disorder of cerebrospinal liquid flow, in combination with a standard imaging method (TDM).
The measurement of noninvasive ICP could allow earlier detection of hydrocephalus or another disorder of cerebrospinal liquid flow, and evaluate whether the increase in ICP precedes patient clinical worsening and / or imaging.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Masking Description: | open |
Primary Purpose: | Diagnostic |
Official Title: | Non Invasive Measurements of Intracranial Pressure After Aneurysmal Subarachnoid Hemorrhage |
Actual Study Start Date : | March 2015 |
Estimated Primary Completion Date : | March 2018 |
Estimated Study Completion Date : | March 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: aneurysmal subarachnoid hemorrhage |
Device: Echodia® hand-held equipment (ELIOS) |
- Presence of an intracranial pressure variation or increase [ Time Frame: at day 1 ]Presence of an intracranial pressure variation or increase when physician has diagnosed a clinical or imaging disorder of the cerebrospinal liquid flow with standard diagnose methods (composite outcome measure): clinical signs, TDM and assessment of bifrontal index.
- Evolution of ICP before and after the development of disorder of the cerebrospinal liquid flow according to clinical sign and/or TDM. [ Time Frame: at day 1 ]
- Efficiency of the measurement device on repetitive measurement during one year as evaluated by composite outcome measure: clinical signs, TDM. [ Time Frame: at day 1 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients which had recently (few days) aneurysmal subarachnoid hemorrhage
- Valid tympanometry test at least for one ear
- Between 18 and 75 years of age
- Cochlear response useful at least for an ear which has validate the tympanometry test
- Written informed consent reviewed and signed by patient
- Affiliation to a social security scheme
Exclusion Criteria:
- Invalid tympanometry test for the both ears
- Collect of cochlear responses impossible for the ear or both ear which validate the tympanometry test
- Patient refusal after enlightened information

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040284
Contact: Patrick LACARIN | 0473751195 | placarin@chu-clermontferrand.fr |
France | |
Chu Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France, 63003 | |
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr | |
Principal Investigator: Paul AVAN |
Responsible Party: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT03040284 |
Other Study ID Numbers: |
CHU-301 2014-A01300-47 ( Other Identifier: 2014-A01300-47 ) |
First Posted: | February 2, 2017 Key Record Dates |
Last Update Posted: | February 2, 2017 |
Last Verified: | January 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
noninvasive monitoring intracranial pressure cochlear electrophysiology |
aneurysmal subarachnoid haemorrhage cerebrovascular disorders brain diseases |
Subarachnoid Hemorrhage Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |