Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement
Stopped early · Not applicable
Conditions studied: Hydrocephalus, Idiopathic Intracranial Hypertension, Pseudotumor Cerebri
In brief
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.
Key facts
- Study ID
- NCT01863381
- Run by
- LifeBridge Health
- People needed
- 5
- Starts
- 2014-09-01
- Expected to finish
- 2015-10-01
- Last updated by the study team
- 2017-08-11
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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