Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Study Overview
Brief 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
Detailed Description
In this study we will prospectively collect relevant clinical data on 60 neurological patients, who are being referred for an elective lumbar puncture (eg. suspected multiple sclerosis, raised intracranial hypertension, etc). Each enrolled patient will be monitored in parallel to the lumbar puncture with the HeadSense ICP monitor. Subjects who meet the study inclusion and exclusion criteria will be enrolled in the study.
Step 1: 10 minute measurement of HeadSense monitor. Once the patient is inclined with his upper body 30 degrees to the bed the pressure values, the clinical procedure can begin. The device must be preset in a continuous monitoring mode. The continuous monitoring allows a loop of measurements for an unlimited time in a rate of four measurements per minute.
Step 2: 10 minute measurement of HeadSense monitor in supine position.
Step 3: Patient will be placed in a left lateral position. The lumbar puncture will be done and CSF pressure will be measured following standard procedures.
Step 4: 10 minute measurement of HeadSense monitor in supine position.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HS-1000 recording
ICP monitoring will be done with the HS-1000 to compare to CSF measurement from lumbar puncture (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals last 10 minutes.
Intervention: HS-1000 (Device)
Outcomes
Primary Outcomes
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Time Frame: 10 minutes
Secondary Outcomes
- Incidence of Adverse events (AEs)(48 hours from the end of monitoring with the HS-1000)