MedTrace Logo

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

NCT01976559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-11

No results posted yet for this study

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).

Conditions

  • Hydrocephalus
  • Shunt Malfunction

Interventions

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.

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.

Sponsors & Collaborators

  • University Hospital, Umeå

    collaborator OTHER

  • LifeBridge Health

    lead OTHER

Principal Investigators

  • Michael A Williams, MD · Sinai Hospital of Baltimore / LifeBridge Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976559 on ClinicalTrials.gov