Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
1 other identifier
interventional
60
3 countries
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 30, 2019
December 1, 2016
1.6 years
May 12, 2016
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
10 minutes
Secondary Outcomes (1)
Incidence of Adverse events (AEs)
48 hours from the end of monitoring with the HS-1000
Study Arms (1)
HS-1000 recording
EXPERIMENTALICP 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HeadSense Medicallead
- Rigshospitalet, Denmarkcollaborator
Study Sites (3)
Rigshospitalet-Glostrup
Copenhagen, Denmark
Asklepios Hospitals Schildautal
Seesen, Germany
Elisabeth/Tweesteden Hospital
Tilburg, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Schytz, MD
Glostrup University Hospital, Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 16, 2016
Study Start
November 1, 2015
Primary Completion
June 1, 2017
Study Completion
December 1, 2017
Last Updated
October 30, 2019
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share