Brain InjuriesNCT02775136
An Evaluation of a Non-invasive Brain Monitor
A study testing HS-1000 recording in people with Brain Injuries and Subarachnoid Hemorrhage, run by HeadSense Medical at 4 sites in Germany.
Trial summary
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial
- What is being tested?
- HS-1000 recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2014to 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
- Adult men and women subjects, aged 18 years old and over at screening visit
- Subjects with neuropathology that the principal investigator considers including in this study.
- Survival expectancy greater than 72 hours
- Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
- Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
Who cannot join
- Local ear infection
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
- Subarachnoid hemorrhage (SAH), Fisher Grade 4
- Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
- Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition)
Trial locations and contacts
4 sites in 1 country.
Thomas Swanson contact
Germany4 sites, 4 recruiting
- Recruiting
Klinikum Darmstadt
Darmstadt, 64283
Rainer Kollmar, Prof., 06151 - 107 4501, Rainer.Kollmar@mail.klinikum-darmstadt.de
Rainer Kollmar, Prof.
- Recruiting
University Hospital Erlangen
Erlangen
Rudolf Rammensee, 09131 85-33001, rudolf.rammensee@uk-erlangen.de
Rudolf Rammensee
- Recruiting
Universitätsklinik Göttingen
Göttingen, 37075
Christian von der Brelie, Dr., cvdb@gmx.net
Christian von der Brelie, Dr.
- Recruiting
Klinikum Stuttgart
Stuttgart
Oliver Ganslandt, Prof., 0711 278-33700, o.ganslandt@klinikum-stuttgart.de
Oliver Ganslandt, Prof.
About this study
Official title: An Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Brain Monitor
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.
Read the detailed description
Non-invasive modality for brain monitoring can potentially serve as a major contribution to conventional monitoring techniques for patients with neuropathologies, to assure minimal discomfort to the bedbound patients, and provide information about critical physiological signs to the physicians. The lack of a precise diagnostic technique for numerous neuropathologies for patients in neurosurgical clinics can further hinder therapeutic effectiveness and, therefore, influence patient recovery and healing. Neuro-critical care involves monitoring standard vital signs and cerebral physiological signs, mainly focusing on intracranial pressure (ICP), temperature, cerebral blood flow velocity, arterial blood pressure, cerebral perfusion pressure, brain tissue oxygenation etc. The collaboration of state of the art brain monitoring vary between different intensive care units serves a significant drawback in some cases, as accuracy of diagnosis and monitoring is challenged and thereby there is an eminent need for interrelationship brain monitoring approach. That can also be leveraged by applying the monitoring noninvasively, as it particularly beneficial for clinical applications that routinely require the inevitable and dynamic transport of patients between hospital units (imaging, surgical room, etc.).
Subjects who meet the inclusion and exclusion criteria for this study, with a signed informed consent form, will be enrolled into the study. Eligible patients will be divided to 2 groups:
- Patients undergoing Invasive ICP monitoring
- Subarachnoid hemorrhage (SAH) patients with Fisher Grade of 3 or 4
The non-invasive measurements recording sessions will be according to the protocol scheme per each group:
- Eligible patients undergoing Invasive ICP monitoring will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for a single recording session.
- Eligible SAH patients with Fisher Grade of 3 or 4 will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for three recording sessions.
For all eligible patients, non-invasive measurements by the HS-1000 device will be conducted in parallel with the standard monitoring modalities, as used at the site without any change in the patient's management.
- Conditions
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus, Brain Neoplasms
- Being tested
- HS-1000 recording
- Keywords
- brain injuries, neurological monitoring
- Medical subject headings
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000 recordingDevice
| Study group | Role | What they receive |
|---|---|---|
| HS-1000 recording | Experimental | Non-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members. Receives: Device: HS-1000 recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recordings that correlate to neuropathology
Demonstrate the HS-1000 performance and accuracy in brain monitoring
Measured: up to 1 hour
Secondary outcomes (2)
Incidence of adverse events
Measured: 48 hours from the end of monitoring with the HS-1000
Rate of ear infections/irritations graded by none/mild/moderate and severe
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 posted17 May 2016 (estimated)
- Study startOct 2014
- 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 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinikum Stuttgart, Klinikum Darmstadt, University Medical Center Goettingen
- Responsible party
- Sponsor
- Investigators
- Oliver Ganslandt, Prof., Principal investigator, Klinikum Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775136
- Sponsor's protocol ID
- HS-011
- Status last verified
- Dec 2016
- First submitted
- 13 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
- An Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Brain Monitor
- ClinicalTrials.gov ID
- NCT02775136
- Acronym / sponsor ID
- HS-011
- Conditions
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus, Brain Neoplasms
- Keywords
- brain injuries, neurological monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Klinikum Stuttgart, Klinikum Darmstadt, University Medical Center Goettingen
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 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.
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.
Detailed description
Non-invasive modality for brain monitoring can potentially serve as a major contribution to conventional monitoring techniques for patients with neuropathologies, to assure minimal discomfort to the bedbound patients, and provide information about critical physiological signs to the physicians. The lack of a precise diagnostic technique for numerous neuropathologies for patients in neurosurgical clinics can further hinder therapeutic effectiveness and, therefore, influence patient recovery and healing. Neuro-critical care involves monitoring standard vital signs and cerebral physiological signs, mainly focusing on intracranial pressure (ICP), temperature, cerebral blood flow velocity, arterial blood pressure, cerebral perfusion pressure, brain tissue oxygenation etc. The collaboration of state of the art brain monitoring vary between different intensive care units serves a significant drawback in some cases, as accuracy of diagnosis and monitoring is challenged and thereby there is an eminent need for interrelationship brain monitoring approach. That can also be leveraged by applying the monitoring noninvasively, as it particularly beneficial for clinical applications that routinely require the inevitable and dynamic transport of patients between hospital units (imaging, surgical room, etc.).
Subjects who meet the inclusion and exclusion criteria for this study, with a signed informed consent form, will be enrolled into the study. Eligible patients will be divided to 2 groups:
- Patients undergoing Invasive ICP monitoring
- Subarachnoid hemorrhage (SAH) patients with Fisher Grade of 3 or 4
The non-invasive measurements recording sessions will be according to the protocol scheme per each group:
- Eligible patients undergoing Invasive ICP monitoring will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for a single recording session.
- Eligible SAH patients with Fisher Grade of 3 or 4 will be monitored by the HS-1000, in parallel to the invasive ICP monitor, for three recording sessions.
For all eligible patients, non-invasive measurements by the HS-1000 device will be conducted in parallel with the standard monitoring modalities, as used at the site without any change in the patient's management.
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-1000 recordingNon-invasive measurements duration with HS-1000 device will be for at least 30 minutes and up to 1 hour of aggregate recording either continuously in the event the patient's clinical condition allows it or in separate recording iterations in the event patient's condition will not allow continuous recording. For each patient, there may be several monitoring intervals from three times a day and up to as long as the patient undergoes brain monitoring, per the discretion of the investigator, patient and/or family members. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men and women subjects, aged 18 years old and over at screening visit
- Subjects with neuropathology that the principal investigator considers including in this study.
- Survival expectancy greater than 72 hours
- Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
- Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Local ear infection
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
- Subarachnoid hemorrhage (SAH), Fisher Grade 4
- Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
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 recording | Device | HS-1000 recording |
Primary outcome
Number of recordings that correlate to neuropathology
Time frame: up to 1 hour
Demonstrate the HS-1000 performance and accuracy in brain monitoring
2 secondary outcomes
Incidence of adverse events
Time frame: 48 hours from the end of monitoring with the HS-1000
Rate of ear infections/irritations graded by none/mild/moderate and severe
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
Oliver Ganslandt, Prof. principal investigator
Klinikum Stuttgart
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 recording in people with Brain Injuries and Subarachnoid Hemorrhage, run by HeadSense Medical at 4 sites in Germany.
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 5 inclusion and 6 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 4 sites in Germany. 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 recordings that correlate to neuropathology (time frame: up to 1 hour). 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.