Status:
TERMINATED
Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
Lead Sponsor:
LifeBridge Health
Conditions:
Hydrocephalus
Idiopathic Intracranial Hypertension
Eligibility:
All Genders
18-65 years
Phase:
NA
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.
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01863381
Start Date
September 1 2014
End Date
October 1 2015
Last Update
August 11 2017
Active Locations (1)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21209