HydrocephalusNCT01976559
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
A study testing Tympanic Membrane Displacement (TMD) and DPOAE in people with Hydrocephalus and Shunt Malfunction, run by LifeBridge Health at 1 site in Sweden.
Trial summary
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hydrocephalus, Shunt Malfunction
- What is being tested?
- Tympanic Membrane Displacement (TMD) and DPOAE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Mar 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of suspected hydrocephalus or shunt malfunction
- CSF infusion testing 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 participate in the study
Who cannot join
- Subject is pregnant
- Subject lacks decision-making capacity
- Subject is unwilling to participate in 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 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.
About this study
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (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 cerebrospinal fluid (CSF) infusion testing.
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, shunt malfunction, or other disorders of CSF circulation who have been recommended on the basis of standard clinical criteria to have CSF infusion testing are eligible.
- Conditions
- Hydrocephalus, Shunt Malfunction
- Being tested
- Tympanic Membrane Displacement (TMD), DPOAE
- Keywords
- ICP, Intracranial pressure, Hydrocephalus, Idiopathic normal pressure hydrocephalus, CSF, Cerebrospinal fluid, Noninvasive ICP
- Medical subject headings
- Hydrocephalus
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 Marchbanks MMS-14 TMD Cerebral Cochlear Fluid Pressure (CCFP) Analyzer
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 each ICP level during the CSF infusion testing, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration.
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 / Shunt Malfunction | Experimental | Patients between the ages of 18-80 years with suspected hydrocephalus, shunt malfunction, or disorders of CSF circulation who are recommended by their doctor based on standard clinical criteria to undergo CSF infusion testing. 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 CSF infusion testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå
- Responsible party
- Sponsor
- Investigators
- Michael A Williams, MD, Principal investigator, Sinai Hospital of Baltimore / LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976559
- Sponsor's protocol ID
- IRB 1964
- Other IDs
- SMST02802
- Status last verified
- Aug 2017
- First submitted
- 30 Oct 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 Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
- ClinicalTrials.gov ID
- NCT01976559
- Acronym / sponsor ID
- IRB 1964
- Conditions
- Hydrocephalus, Shunt Malfunction
- Keywords
- ICP, Intracranial pressure, Hydrocephalus, Idiopathic normal pressure hydrocephalus, CSF, Cerebrospinal fluid, Noninvasive ICP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- University Hospital, Umeå
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Nov 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 spinal fluid, also known as intracranial pressure (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 cerebrospinal fluid (CSF) infusion testing.
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, shunt malfunction, or other disorders of CSF circulation who have been recommended on the basis of standard clinical criteria to have CSF infusion testing are eligible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrocephalus / Shunt Malfunction | Experimental | Device: Tympanic Membrane Displacement (TMD), Device: DPOAEPatients between the ages of 18-80 years with suspected hydrocephalus, shunt malfunction, or disorders of CSF circulation who are recommended by their doctor based on standard clinical criteria to undergo CSF infusion testing. The interventions include tympanic membrane displacement (TMD) and DPOAE. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of suspected hydrocephalus or shunt malfunction
- CSF infusion testing 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 to participate in 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: Marchbanks MMS-14 TMD Cerebral Cochlear Fluid Pressure (CCFP) AnalyzerThe 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 each ICP level during the CSF infusion testing, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration. | Device | Hydrocephalus / Shunt Malfunction |
| 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 / Shunt Malfunction |
Primary outcome
Noninvasive ICP
Time frame: Day 1 (Concurrent with CSF infusion testing)
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
Sinai Hospital of Baltimore / 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 Shunt Malfunction, run by LifeBridge Health at 1 site in Sweden.
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: finished, 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 CSF infusion testing)). 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.