Intracranial HypertensionNCT02773901
Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
A study testing HS-1000 in people with Intracranial Hypertension, run by HeadSense Medical at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- HS-1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
Thomas Swanson contact
3 sites in 3 countries
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet-Glostrup
Copenhagen
Henrik Schytz, MD, 2876 1824, henrikschytz@hotmail.com
Henrik Schytz, MD
Germany1 site, 1 recruiting
- Recruiting
Asklepios Hospitals Schildautal
Seesen
Mark Obermann, MD, mark.obermann@uni-due.de
Mark Obermann, MD
Netherlands1 site, 1 recruiting
- Recruiting
Elisabeth/Tweesteden Hospital
Tilburg
Guus Schoonman, MD, PhD, g.schoonman@tsz.nl
Guus Schoonman, MD, PhD
About this study
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
Read the 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.
- Conditions
- Intracranial Hypertension
- Being tested
- HS-1000
- Keywords
- intracranial pressure, noninvasive monitoring, lumbar puncture
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000Device
| Study group | Role | What they receive |
|---|---|---|
| HS-1000 recording | Experimental | 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. Receives: Device: HS-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Measured: 10 minutes
Secondary outcomes (1)
Incidence of Adverse events (AEs)
Measured: 48 hours from the end of monitoring with the HS-1000
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Henrik Schytz, MD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773901
- Sponsor's protocol ID
- HS-031
- Status last verified
- Dec 2016
- First submitted
- 12 May 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement
- ClinicalTrials.gov ID
- NCT02773901
- Acronym / sponsor ID
- HS-031
- Conditions
- Intracranial Hypertension
- Keywords
- intracranial pressure, noninvasive monitoring, lumbar puncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Nov 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-1000 recording | Experimental | Device: HS-1000ICP 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-1000 | Device | HS-1000 recording |
Primary outcome
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards
Time frame: 10 minutes
1 secondary outcome
Incidence of Adverse events (AEs)
Time frame: 48 hours from the end of monitoring with the HS-1000
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Swanson contact
Henrik Schytz, MD principal investigator
Glostrup University Hospital, Copenhagen
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 in people with Intracranial Hypertension, run by HeadSense Medical at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Swanson (thomas@head-sense-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICP values obtained by the HeadSense device that correlate to ICP using current standards (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.