Clinical trial NCT02773901: Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
Official title: Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Hypertension
Keywords: intracranial pressure
noninvasive monitoring
lumbar puncture
Lead sponsor: HeadSense Medical
Sponsor class: INDUSTRY
Collaborators: name: Rigshospitalet, Denmark
First posted: 2016-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Lumbar puncture and HeadSense measurement will be done by two different doctors and they will not share measurement values during the procedure.

After the study the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. Patient adverse events will be documented on the case report forms in case they occurred and the family or advocate of the patient will be informed. In case of clinical relevant adverse events appropriate clinical action will be taken.

As the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. Patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.

Eligibility criteria: 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

Primary outcomes:
measure: Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
timeFrame: 10 minutes
Secondary outcomes:
measure: Incidence of Adverse events (AEs)
timeFrame: 48 hours from the end of monitoring with the HS-1000
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet-Glostrup
city: Seesen
country: Germany
facility: Asklepios Hospitals Schildautal
city: Tilburg
country: Netherlands
facility: Elisabeth/Tweesteden Hospital
Study officials:
affiliation: Rigshospitalet-Glostrup
name: Henrik Schytz, MD
role: PRINCIPAL_INVESTIGATOR
References: