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Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol

Primary Purpose

Hydrocephalus, Shunt Malfunction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tympanic Membrane Displacement (TMD)
DPOAE
Sponsored by
LifeBridge Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hydrocephalus focused on measuring ICP, Intracranial pressure, Hydrocephalus, Idiopathic normal pressure hydrocephalus, CSF, Cerebrospinal fluid, Noninvasive ICP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Umea Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrocephalus / Shunt Malfunction

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 30, 2013
Last Updated
August 9, 2017
Sponsor
LifeBridge Health
Collaborators
University Hospital, Umeå
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1. Study Identification

Unique Protocol Identification Number
NCT01976559
Brief Title
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
Official Title
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeBridge Health
Collaborators
University Hospital, Umeå

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydrocephalus, Shunt Malfunction
Keywords
ICP, Intracranial pressure, Hydrocephalus, Idiopathic normal pressure hydrocephalus, CSF, Cerebrospinal fluid, Noninvasive ICP

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrocephalus / Shunt Malfunction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tympanic Membrane Displacement (TMD)
Other Intervention Name(s)
Marchbanks MMS-14 TMD Cerebral Cochlear Fluid Pressure (CCFP) Analyzer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
DPOAE
Other Intervention Name(s)
Distortion Product Otoacoustic Emissions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Noninvasive ICP
Description
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
Time Frame
Day 1 (Concurrent with CSF infusion testing)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Williams, MD
Organizational Affiliation
Sinai Hospital of Baltimore / LifeBridge Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Umea Hospital
City
Umea
Country
Sweden

12. IPD Sharing Statement

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Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol

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