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

Primary Purpose

Intracranial Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HS-1000
Sponsored by
HeadSense Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intracranial Hypertension focused on measuring intracranial pressure, noninvasive monitoring, lumbar puncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet-GlostrupRecruiting
  • Asklepios Hospitals SchildautalRecruiting
  • Elisabeth/Tweesteden HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HS-1000 recording

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards

Secondary Outcome Measures

Incidence of Adverse events (AEs)

Full Information

First Posted
May 12, 2016
Last Updated
October 29, 2019
Sponsor
HeadSense Medical
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02773901
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeadSense Medical
Collaborators
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
intracranial pressure, noninvasive monitoring, lumbar puncture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HS-1000 recording
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
HS-1000
Primary Outcome Measure Information:
Title
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Incidence of Adverse events (AEs)
Time Frame
48 hours from the end of monitoring with the HS-1000

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Swanson
Email
thomas@head-sense-med.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Hromyak
Phone
216-526-8534
Email
dana@head-sense-med.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Schytz, MD
Organizational Affiliation
Rigshospitalet-Glostrup
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet-Glostrup
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Schytz, MD
Phone
2876 1824
Email
henrikschytz@hotmail.com
First Name & Middle Initial & Last Name & Degree
Henrik Schytz, MD
Facility Name
Asklepios Hospitals Schildautal
City
Seesen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Obermann, MD
Email
mark.obermann@uni-due.de
First Name & Middle Initial & Last Name & Degree
Mark Obermann, MD
Facility Name
Elisabeth/Tweesteden Hospital
City
Tilburg
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guus Schoonman, MD, PhD
Email
g.schoonman@tsz.nl
First Name & Middle Initial & Last Name & Degree
Guus Schoonman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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