Brain InjuriesNCT02773862
Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
A study testing HS-1000 in people with Brain Injuries and Intracranial Hypertension, run by HeadSense Medical at 1 site in Netherlands.
Trial summary
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, 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
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Oct 2015
- 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
- Have an invasive ICP monitoring
- Male or Female in the age range of 18 years and older
Who cannot join
- Local infection in the ear.
- Pregnant/lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. An increase in the intracranial pressure might suggest secondary neurological deterioration and is considered an alarming symptom. Current practice is to insert an invasive monitor through a burr hole in the skull with the risk of bleeding and infection. 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 pilot study, the investigators will prospectively collect relevant clinical data on 15 TBI patients with an inserted invasive ICP monitor. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's ICP monitor. Subjects who meet the study's inclusion and exclusion criteria will be enrolled in the study. Family members will be asked for consent. The patient's clinical condition will be recorded in a case record form (CRF).
Once the patient is inclined with his upper body 30 degrees to the bed and the invasive ICP monitor displays the pressure values, the clinical procedure can begin. Once the HeadSense's monitor is calibrated it is connected to the front end that is placed on the patient's ears. Each recording session will be ½-48 hours long, depending on the patient's clinical condition. In case the ICP monitor is still inserted to the patient's brain in the following day, recording sessions will continue until the ICP monitor is removed.
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 event, 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.
Once the data collection is done, results will be analyzed by comparing ICP readings from both devices. The end point of the study is to collect at least half an hour of ICP monitoring for each participant.
- Conditions
- Brain Injuries, Intracranial Hypertension
- Being tested
- HS-1000
- Keywords
- brain injuries, noninvasive monitoring, intracranial pressure
- Medical subject headings
- Brain Injuries, 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 in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition. 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 HS device that correlate to ICP using current standards
Measured: 30 minutes
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 startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Guus Schoonman, MD, PhD, Principal investigator, St. Elisabeth/Tweesteden Hospital Tilburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773862
- Sponsor's protocol ID
- HS-012
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 17 May 2016
- 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 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Non-invasive ICP HeadSense Monitor in TBI Patients Undergoing Invasive ICP Monitoring
- ClinicalTrials.gov ID
- NCT02773862
- Acronym / sponsor ID
- HS-012
- Conditions
- Brain Injuries, Intracranial Hypertension
- Keywords
- brain injuries, noninvasive monitoring, intracranial pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Elisabeth-TweeSteden Ziekenhuis
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- 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.
Patients with severe traumatic brain injury (TBI) are admitted to the intensive care unit (ICU). Under certain condition (such as a impaired consciousness) the intracranial pressure (ICP) is measured. An increase in the intracranial pressure might suggest secondary neurological deterioration and is considered an alarming symptom. Current practice is to insert an invasive monitor through a burr hole in the skull with the risk of bleeding and infection. Using a new type of ICP monitor (HeadSense) it is possible to measure ICP non-invasively through an acoustic signal.
Detailed description
In this pilot study, the investigators will prospectively collect relevant clinical data on 15 TBI patients with an inserted invasive ICP monitor. Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the HeadSense's ICP monitor. Subjects who meet the study's inclusion and exclusion criteria will be enrolled in the study. Family members will be asked for consent. The patient's clinical condition will be recorded in a case record form (CRF).
Once the patient is inclined with his upper body 30 degrees to the bed and the invasive ICP monitor displays the pressure values, the clinical procedure can begin. Once the HeadSense's monitor is calibrated it is connected to the front end that is placed on the patient's ears. Each recording session will be ½-48 hours long, depending on the patient's clinical condition. In case the ICP monitor is still inserted to the patient's brain in the following day, recording sessions will continue until the ICP monitor is removed.
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 event, 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.
Once the data collection is done, results will be analyzed by comparing ICP readings from both devices. The end point of the study is to collect at least half an hour of ICP monitoring for each participant.
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 in parallel for both HS-1000 and ICP monitoring via an invasive monitoring device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 48 hours, continuously depending on the patient's clinical condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have an invasive ICP monitoring
- Male or Female in the age range of 18 years and older
Key exclusion criteria (2 listed)
- Local infection in the ear.
- Pregnant/lactating women
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 HS device that correlate to ICP using current standards
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- 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.
Guus Schoonman, MD, PhD principal investigator
St. Elisabeth/Tweesteden Hospital Tilburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 in people with Brain Injuries and Intracranial Hypertension, run by HeadSense Medical at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICP values obtained by the HS device that correlate to ICP using current standards (time frame: 30 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 17 May 2016.