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

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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

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.
    


Study Type

Interventional


Primary Outcome

Noninvasive ICP


Condition

Hydrocephalus

Intervention

Tympanic Membrane Displacement (TMD)

Study Arms / Comparison Groups

 Hydrocephalus / Shunt Malfunction
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

November 2013

Completion Date

March 2014

Primary Completion Date

March 2014

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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Michael A Williams, MD, , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT01976559

Organization ID

IRB 1964

Secondary IDs

SMST02802

Responsible Party

Sponsor

Study Sponsor

LifeBridge Health

Collaborators

 University Hospital, Umeå

Study Sponsor

Michael A Williams, MD, Principal Investigator, Sinai Hospital of Baltimore / LifeBridge Health


Verification Date

August 2017