HydrocephalusNCT01863381
Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
A study testing Tympanic membrane displacement (TMD) and DPOAE in people with Hydrocephalus and Idiopathic Intracranial Hypertension, run by LifeBridge Health at 1 site in United States.
Trial summary
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hydrocephalus, Idiopathic Intracranial Hypertension, Pseudotumor Cerebri
- What is being tested?
- Tympanic membrane displacement (TMD) and DPOAE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of suspected symptomatic hydrocephalus or idiopathic intracranial hypertension (pseudotumor cerebri)
- ICP monitoring via 25-ga needle in an existing shunt reservoir or ICP monitoring via spinal catheter has been recommended on the basis of standard clinical criteria
- Capable of providing valid signed informed consent
- Normal middle-ear function as determined by tympanometry
- DPOAE meet criteria that are required for the research
- Acoustic stapedial reflex meets criteria that are required for the research
- Subject is willing and able to return for the study
Who cannot join
- Subject is pregnant
- Subject lacks decision-making capacity
- Subject is unwilling or unable to return for the study
- Prior middle-ear disease or surgery, with the exception of tympanostomy tubes that have been removed and are healed
- Participating in the study would significantly delay or interfere with the subject's healthcare
- Subject has excess ear wax that cannot be removed safely and could potentially be pushed onto the ear drum by the insertion of the ear plugs needed for the testing
- The TMD or DPOAE do not respond to a change in posture from lying flat to standing up, which means that the anatomic connection between the inner ear and the CSF is absent
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore
Baltimore, Maryland, 21209
About this study
Official title: Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement: Continuous Intracranial Pressure Monitoring Subprotocol
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.
Read the detailed description
Recently, astronauts in long-duration spaceflight have been found to have a syndrome consisting of swelling of the optic nerve, impaired vision, and elevated cerebrospinal fluid pressure (also known as intracranial pressure [ICP]) via lumbar puncture (LP), which is similar to the syndrome of idiopathic intracranial hypertension (IIH). In astronauts, this syndrome is called Visual Impairment/Intracranial Pressure (VIIP). It is not possible to perform an LP on astronauts in space. Noninvasive methods of estimating ICP exist but have not been tested against continuous ICP methods in a patient cohort that is physiologically similar to that of astronauts.
The primary objective of this study is to determine the validity, reliability, accuracy, and precision of two noninvasive methods of ICP measurement (tympanic membrane displacement (TMD, Marchbanks Measurements Systems, UK) and distortion product otoacoustic emissions (DPOAE) in comparison to a reference standard, invasive ICP measurement, in human subjects undergoing diagnostic ICP monitoring.
The two noninvasive methods are based on the responses of the inner ear and middle ear to changes in ICP. The first method is TMD, which measures tiny movements of the ear drum, and the second is DPOAE, which is routinely used for newborn hearing screening.
Adults with hydrocephalus or pseudotumor cerebri who have been recommended on the basis of standard clinical criteria to have ICP monitoring either by insertion of a temporary spinal catheter or by insertion of a needle into an existing shunt reservoir are eligible.
After insertion of the spinal catheter or the needle in the shunt, subjects will undergo testing with the TMD and DPOAE in the lying, sitting, standing, and head-down tilt (10 degrees) position. In addition, testing will be performed during sleep, when normal fluctuations of ICP occur.
Diagnostic decisions will be based on the standard invasive ICP monitoring only, and not based on the noninvasive ICP monitoring.
- Being tested
- Tympanic membrane displacement (TMD), DPOAE
- Keywords
- Hydrocephalus, Idiopathic intracranial hypertension, Pseudotumor cerebri, ICP, Intracranial pressure, CSF pressure, VIIP
- Medical subject headings
- Hydrocephalus, Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanic membrane displacement (TMD)Device
Also called Cerebral and Cochlear Fluid Pressure Analyzer (CCFP), Marchbanks, CCFP
The CCFP Analyser has a passive mode and an active mode. When used in active mode, the device generates a tone burst that is transmitted to the ear to elicit contraction of the stapedius muscle. The passive mode requires no stimulus or sound burst.
For the lying, sitting, standing, and 10-degree head-down tilt conditions, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration.
Overnight recording of non-invasive ICP will be done using the passive mode of the CCFP device.
DPOAEDevice
Also called Distortion Product Otoacoustic Emissions
DPOAE measurement uses a clinical acoustic probe to record the ear's response to two simultaneous tones. DPOAE measurements will be made for 13 tones. The total measurement time for each condition is 2-4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocephalus/Pseudotumor | Experimental | Patients between the ages of 18-65 years with suspected hydrocephalus or idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri, who are recommended by their doctor based on standard clinical criteria to undergo intracranial pressure monitoring. The interventions include tympanic membrane displacement (TMD) and DPOAE. Receives: Device: Tympanic membrane displacement (TMD); Device: DPOAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninvasive ICP
Bland-Altman analysis: the difference between the noninvasive ICP and the invasive ICP is plotted against the mean of both the noninvasive and invasive ICP at each ICP level
Measured: Day 1 (Concurrent with invasive ICP monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionOct 2015
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A. Williams, MD, Principal investigator, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863381
- Sponsor's protocol ID
- SMST02802
- Status last verified
- Aug 2017
- First submitted
- 22 May 2013
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement: Continuous Intracranial Pressure Monitoring Subprotocol
- ClinicalTrials.gov ID
- NCT01863381
- Acronym / sponsor ID
- SMST02802
- Keywords
- Hydrocephalus, Idiopathic intracranial hypertension, Pseudotumor cerebri, ICP, Intracranial pressure, CSF pressure, VIIP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 May 2013 (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.
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.
Detailed description
Recently, astronauts in long-duration spaceflight have been found to have a syndrome consisting of swelling of the optic nerve, impaired vision, and elevated cerebrospinal fluid pressure (also known as intracranial pressure [ICP]) via lumbar puncture (LP), which is similar to the syndrome of idiopathic intracranial hypertension (IIH). In astronauts, this syndrome is called Visual Impairment/Intracranial Pressure (VIIP). It is not possible to perform an LP on astronauts in space. Noninvasive methods of estimating ICP exist but have not been tested against continuous ICP methods in a patient cohort that is physiologically similar to that of astronauts.
The primary objective of this study is to determine the validity, reliability, accuracy, and precision of two noninvasive methods of ICP measurement (tympanic membrane displacement (TMD, Marchbanks Measurements Systems, UK) and distortion product otoacoustic emissions (DPOAE) in comparison to a reference standard, invasive ICP measurement, in human subjects undergoing diagnostic ICP monitoring.
The two noninvasive methods are based on the responses of the inner ear and middle ear to changes in ICP. The first method is TMD, which measures tiny movements of the ear drum, and the second is DPOAE, which is routinely used for newborn hearing screening.
Adults with hydrocephalus or pseudotumor cerebri who have been recommended on the basis of standard clinical criteria to have ICP monitoring either by insertion of a temporary spinal catheter or by insertion of a needle into an existing shunt reservoir are eligible.
After insertion of the spinal catheter or the needle in the shunt, subjects will undergo testing with the TMD and DPOAE in the lying, sitting, standing, and head-down tilt (10 degrees) position. In addition, testing will be performed during sleep, when normal fluctuations of ICP occur.
Diagnostic decisions will be based on the standard invasive ICP monitoring only, and not based on the noninvasive ICP monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrocephalus/Pseudotumor | Experimental | Device: Tympanic membrane displacement (TMD), Device: DPOAEPatients between the ages of 18-65 years with suspected hydrocephalus or idiopathic intracranial hypertension (IIH), also known as pseudotumor cerebri, who are recommended by their doctor based on standard clinical criteria to undergo intracranial pressure monitoring. The interventions include tympanic membrane displacement (TMD) and DPOAE. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of suspected symptomatic hydrocephalus or idiopathic intracranial hypertension (pseudotumor cerebri)
- ICP monitoring via 25-ga needle in an existing shunt reservoir or ICP monitoring via spinal catheter has been recommended on the basis of standard clinical criteria
- Capable of providing valid signed informed consent
- Normal middle-ear function as determined by tympanometry
- DPOAE meet criteria that are required for the research
Key exclusion criteria (7 listed)
- Subject is pregnant
- Subject lacks decision-making capacity
- Subject is unwilling or unable to return for the study
- Prior middle-ear disease or surgery, with the exception of tympanostomy tubes that have been removed and are healed
- Participating in the study would significantly delay or interfere with the subject's healthcare
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 |
|---|---|---|
| Tympanic membrane displacement (TMD)Also: Cerebral and Cochlear Fluid Pressure Analyzer (CCFP), Marchbanks, CCFPThe CCFP Analyser has a passive mode and an active mode. When used in active mode, the device generates a tone burst that is transmitted to the ear to elicit contraction of the stapedius muscle. The passive mode requires no stimulus or sound burst. For the lying, sitting, standing, and 10-degree head-down tilt conditions, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration. Overnight recording of non-invasive ICP will be done using the passive mode of the CCFP device. | Device | Hydrocephalus/Pseudotumor |
| DPOAEAlso: Distortion Product Otoacoustic EmissionsDPOAE measurement uses a clinical acoustic probe to record the ear's response to two simultaneous tones. DPOAE measurements will be made for 13 tones. The total measurement time for each condition is 2-4 minutes. | Device | Hydrocephalus/Pseudotumor |
Primary outcome
Noninvasive ICP
Time frame: Day 1 (Concurrent with invasive ICP monitoring)
Bland-Altman analysis: the difference between the noninvasive ICP and the invasive ICP is plotted against the mean of both the noninvasive and invasive ICP at each ICP level
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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.
Michael A. Williams, MD principal investigator
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympanic membrane displacement (TMD) and DPOAE in people with Hydrocephalus and Idiopathic Intracranial Hypertension, run by LifeBridge Health at 1 site in United States.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Aug 2017. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninvasive ICP (time frame: Day 1 (Concurrent with invasive ICP monitoring)). 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 11 Aug 2017.