UnknownNot Applicable

Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement

Denmark, Germany, Netherlands60 participantsStarted 2015-11

Plain-language summary

In current practice patients with a suspected increase of intracranial pressure (ICP) will undergo a lumbar puncture with measurement of cerebral spinal fluid (CSF) pressure (as a marker for ICP). A lumbar puncture is an invasive and sometimes painful procedure. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or Female in the age range of 18 years and older * All patients who are referred for elective or subacute lumbar puncture including CSF pressure measurement Exclusion Criteria: * Local infection in the ear * Pregnant or lactating women * Cervical spine stenose * Arnold-Chiari malformations * Aqueductal stenosis or other changes causing an uneven CSF pressure between different compartments * Mass lesions * Current or previous craniotomy or craniectomies * Suspicion of meningitis or encephalitis

What they're measuring

Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards

Timeframe: 10 minutes

Trial details

NCT IDNCT02773901

SponsorHeadSense Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06

Contact for this trial

Thomas Swanson

thomas@head-sense-med.com

View on ClinicalTrials.gov More Intracranial Hypertension trials