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Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement

NCT01863381 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

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 cerebrospinal fluid (CSF), also known as intracranial pressure or ICP.

Conditions

  • Hydrocephalus
  • Idiopathic Intracranial Hypertension
  • Pseudotumor Cerebri

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 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.

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

  • LifeBridge Health

    lead OTHER

Principal Investigators

  • Michael A. Williams, MD · LifeBridge Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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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 NCT01863381 on ClinicalTrials.gov