NCT01863381

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

May 22, 2013

Last Update Submit

August 9, 2017

Conditions

HydrocephalusIdiopathic Intracranial HypertensionPseudotumor Cerebri

Keywords

HydrocephalusIdiopathic intracranial hypertensionPseudotumor cerebriICPIntracranial pressureCSF pressureVIIP

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 1 (Concurrent with invasive ICP monitoring)

Study Arms (1)

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.

Device: Tympanic membrane displacement (TMD)Device: DPOAE

Interventions

Tympanic membrane displacement (TMD)DEVICE

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.

Also known as: Cerebral and Cochlear Fluid Pressure Analyzer (CCFP), Marchbanks, CCFP
Hydrocephalus/Pseudotumor
DPOAEDEVICE

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.

Also known as: Distortion Product Otoacoustic Emissions
Hydrocephalus/Pseudotumor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Conditions

HydrocephalusPseudotumor Cerebri

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial Hypertension

Study Officials

  • Michael A. Williams, MD

    LifeBridge Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 29, 2013

Study Start

September 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

US(1)