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

October 29, 2019 updated by: HeadSense Medical
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
  • Germany
      • Seesen, Germany
        • Recruiting
        • Asklepios Hospitals Schildautal
        • Contact:
        • Principal Investigator:
          • Mark Obermann, MD
  • Netherlands
      • Tilburg, Netherlands
        • Recruiting
        • Elisabeth/Tweesteden Hospital
        • Contact:
        • Principal Investigator:
          • Guus Schoonman, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: HS-1000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse events (AEs)
Time Frame: 48 hours from the end of monitoring with the HS-1000
48 hours from the end of monitoring with the HS-1000

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HeadSense Medical

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Henrik Schytz, MD, Rigshospitalet-Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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