NCT01976559

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

October 30, 2013

Last Update Submit

August 9, 2017

Conditions

HydrocephalusShunt Malfunction

Keywords

ICPIntracranial pressureHydrocephalusIdiopathic normal pressure hydrocephalusCSFCerebrospinal fluidNoninvasive ICP

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 CSF infusion testing)

Study Arms (1)

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.

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 each ICP level during the CSF infusion testing, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration.

Also known as: Marchbanks MMS-14 TMD Cerebral Cochlear Fluid Pressure (CCFP) Analyzer
Hydrocephalus / Shunt Malfunction
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 / Shunt Malfunction

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Umea Hospital

Umeå, Sweden

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Michael A Williams, MD

    Sinai Hospital of Baltimore / LifeBridge Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 6, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

SE(1)