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

Status Unknown status

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Intracranial Hypertension

Clinical Trial Details

NCT number	NCT02773901
Study type	Interventional
Source	HeadSense Medical
Contact	Thomas Swanson
Email	thomas@head-sense-med.com
Status	Unknown status
Phase	N/A
Start date	November 2015
Completion date	December 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms