Trial record 18 of 39 for:    Open Studies | "Hydrocephalus"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by LifeBridge Health
Sponsor:
Collaborator:
University Hospital, Umeå
Information provided by (Responsible Party):
LifeBridge Health
ClinicalTrials.gov Identifier:
NCT01976559
First received: October 30, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Hydrocephalus
Shunt Malfunction
Device: Tympanic Membrane Displacement (TMD)
Device: DPOAE

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol

Resource links provided by NLM:


Further study details as provided by LifeBridge Health:

Primary Outcome Measures:
  • Noninvasive ICP [ Time Frame: Day 1 (Concurrent with CSF infusion testing) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 16
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocephalus / Shunt Malfunction
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.
Device: Tympanic Membrane Displacement (TMD)

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.

Other Name: Marchbanks MMS-14 TMD Cerebral Cochlear Fluid Pressure (CCFP) Analyzer
Device: DPOAE
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.
Other Name: Distortion Product Otoacoustic Emissions

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976559

Contacts
Contact: Michael A Williams, MD 410-601-1900 michwill@lifebridgehealth.org
Contact: Alanvin Orpia, BSN, RN 410-601-0960 aorpia@lifebridgehealth.org

Locations
Sweden
University of Umea Hospital Recruiting
Umea, Sweden
Contact: Jan Malm, MD    +46 090-785-1996    jan.malm@neuro.umu.se   
Sub-Investigator: Anders Eklund, PhD         
Principal Investigator: Jan Malm, MD         
Sponsors and Collaborators
LifeBridge Health
University Hospital, Umeå
Investigators
Principal Investigator: Michael A Williams, MD Sinai Hospital of Baltimore / LifeBridge Health
  More Information

No publications provided

Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT01976559     History of Changes
Other Study ID Numbers: IRB 1964, SMST02802
Study First Received: October 30, 2013
Last Updated: December 9, 2013
Health Authority: Sweden: Regional Ethical Review Board
United States: Institutional Review Board

Keywords provided by LifeBridge Health:
ICP
Intracranial pressure
Hydrocephalus
Idiopathic normal pressure hydrocephalus
CSF
Cerebrospinal fluid
Noninvasive ICP

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 18, 2014