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

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ClinicalTrials.gov Identifier: NCT02773901
Recruitment Status : Unknown
Verified December 2016 by HeadSense Medical.
Recruitment status was:  Recruiting
First Posted : May 16, 2016
Last Update Posted : December 23, 2016
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
HeadSense Medical

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

Condition or disease Intervention/treatment Phase
Intracranial Hypertension Device: HS-1000 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
Study Start Date : November 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. Incidence of Adverse events (AEs) [ Time Frame: 48 hours from the end of monitoring with the HS-1000 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773901


Contacts
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Contact: Thomas Swanson 410-245-9782 thomas@head-sense-med.com
Contact: Dana Hromyak 216-526-8534 dana@head-sense-med.com

Locations
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Denmark
Rigshospitalet-Glostrup Recruiting
Copenhagen, Denmark
Contact: Henrik Schytz, MD    2876 1824    henrikschytz@hotmail.com   
Principal Investigator: Henrik Schytz, MD         
Germany
Asklepios Hospitals Schildautal Recruiting
Seesen, Germany
Contact: Mark Obermann, MD       mark.obermann@uni-due.de   
Principal Investigator: Mark Obermann, MD         
Netherlands
Elisabeth/Tweesteden Hospital Recruiting
Tilburg, Netherlands
Contact: Guus Schoonman, MD, PhD       g.schoonman@tsz.nl   
Principal Investigator: Guus Schoonman, MD, PhD         
Sponsors and Collaborators
HeadSense Medical
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Henrik Schytz, MD Rigshospitalet-Glostrup

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Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02773901     History of Changes
Other Study ID Numbers: HS-031
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HeadSense Medical:
intracranial pressure
noninvasive monitoring
lumbar puncture

Additional relevant MeSH terms:
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Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases