Vasospasm, IntracranialNCT02704637
An Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm
A study testing HS-1000 in people with Vasospasm, Intracranial and Subarachnoid Hemorrhage, run by HeadSense Medical at 1 site in United States.
Trial summary
HeadSense (HS)-1000 device, a proprietary 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
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2017to Dec 2018
- 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 at least 18 years of age inclusive at the time of hospital admission for stabilization and treatment of the SAH
- Subjects receiving intensive care neurological monitoring per standard care following treatment of SAH
- Subject or legal authorized representative is able and willing to comply with the requirements of the protocol
- Subject or legal authorized representative is able to understand and sign written informed consent to participate in the study
- Subject is expected to undergo standard care neurological intensive monitoring for a maximum of 14 days
- Confirmed presence of a ruptured saccular aneurysm on angiography (catheter or CTA) and treated by neurosurgical clipping or endovascular coiling.
- Patient must have a modified Fisher of II to IV.
- The SAH should be between grades I-IV as defined by the World Federation of Neurological Surgery (WFNS).
Who cannot join
- Subject with ear disease, ear trauma
- Subjects with dural defects, punctures
- Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
- Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
- Reported allergy or hypersensitivity to any of the test materials or contraindication to test materials
- 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)
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- 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)
- Patients who have a modified Fisher of 0 to I
- Patients who have a WFNS of V
- Presence of an intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH
- Angiographic vasospasm prior to aneurysm repair procedure, as documented by catheter angiogram or CTA
Trial locations and contacts
1 site in 1 country.
Thomas Swanson contact
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
E. Francois Aldrich, MD, 410-328-0937, FAldrich@Smail.umaryland.edu
E. Francois Aldrich, MD
About this study
HeadSense (HS)-1000 device, a proprietary 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. The investigators hypothesize that the HS-1000 is capable of detecting vasospasm using the raw acoustic data derived from the noninvasive procedure.
Read the detailed description
The study will be an open-label, non-randomized, prospective study in patients with elevated risk of vasospasm after stabilizing the patient and treating the subarachnoid hemorrhage (SAH) to prevent further re-bleeds.
Each enrolled patient will be monitored with the HS-1000 device for a period of 10 minutes, occurring daily, after completion of surgery for SAH. Following admittance to the intensive care unit (ICU), patients will undergo routine monitoring as per standard of care. Non-invasive recordings of 10 minutes in duration with HS-1000 device will be completed daily for up to 14 days contingent on staff availability and the patient's clinical status. In the event a monitoring session is interrupted or postponed, another attempt to re-monitor will be made when the patient is able. Flexibility will granted in lieu of patient or study team unavailability thereby allowing recording to be neglected for any given day if absolutely necessary.
In the case the principle investigator (PI) or a member of the study team positively confirms vasospasm based on clinical assessment or follow-up care of the patient during the monitoring period, the patient will be recorded twice daily for up to a consecutive 14 days or for their duration in the ICU. The PI will determine the severity of vasospasm as per the vasospasm severity scale. Increased recording frequency will be implemented only for patients with vasospasm graded as asymptomatic moderate-to-severe or symptomatic mild-to-severe (i.e. those scoring 2a, 3a, 1s, 2s, or 3s).
Prior to the HS-1000 recording session, the front-end will be placed in the patient's ears and connected to the monitor. The acoustic signal propagates through the cranium, and attenuates during its propagation. The receiving sensor in the other headset picks up the acoustic signal. The receiving sensor converts the acoustical signal into a digital signal and transmits it back to the monitor.
Each recording session with the HS-1000 will last 10 consecutive minutes, if the patient's condition and clinical workflow permits. If required by the attending medical staff, the recording can be stopped and restarted at a later time during the day. The HS-1000 will be used as a seamless adjunctive, state-of-the-art, brain monitoring utility operating in parallel with standard care intensive neurological monitoring modalities. The non-invasive monitor will not replace or alter the standard care received by patients. Once all recordings are completed, the brain monitoring signals will be saved in the study's database.
Daily neurological checks and collection of all routine clinical and radiographic data as per standard of care will be gathered as the gold standard data for statistical comparison. Neurocognitive tests will be performed routinely every 8 hours by attending physicians to assess for neuro-deterioration and radiological (Computed tomographic angiography (CTA) and Digital subtraction angiography (DSA) components. Data collected from patients will be stripped of all personal health identifiers. Each subject will receive a unique identifying patient number linking the individual to their deidentified clinical data set. Only the medical staff attending to the patient's standard care will be knowledgeable to the identity of the subject.
Once data is collected, results of the HS-1000 recording sessions will be analyzed and correlated with deidentified supporting clinical/radiological data to assist in the identification of vasospasm-specific acoustic waveform patterns.
Deidentified supporting clinical data will consist of standard care intensive neurological monitoring procedures currently used to confirm clinical diagnosis of vasospasm, principally based on evidence of neuro deterioration:
- Computed tomographic angiography
- Digital subtraction angiography
- Neurocognitive clinical assessments
- Routine clinical data as per standard of care
Study workflow and HS-1000 recording sessions will be fully compatible with and will not alter the standard of care received by the patients in any way.
- Conditions
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- Being tested
- HS-1000
- Keywords
- vasospasm
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000Device
HeadSense (HS)-1000 device, a proprietary 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
| Study group | Role | What they receive |
|---|---|---|
| HS-1000 recording | Experimental | Each non-invasive recording session with the HS-1000 device will be done for 10 consecutive uninterrupted minutes. Patients will be recorded once daily for the duration of their time in ICU or for up to 14 days total. In the case the PI or a member of the study team positively confirms vasospasm based on clinical assessment or follow-up care during the monitoring period, the patient will be recorded twice daily for up to 14 consecutive days or for their duration in the ICU. Receives: Device: HS-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The HS-1000 will measure intracranial pressure readings from the patient which will then be used to generate vasospasm-specific acoustic waveform patterns.
Development of vasospasm-specific acoustic waveform patterns
Measured: 14 days following SAH
To compare the HS-1000 ability and accuracy in detecting vasospasm by measuring ICP values compared to other standard of care vasospasm diagnostic modalities such as DSA and CTA.
Detection of vasospasm
Measured: 14 days following SAH
To determine HS-1000's ability and accuracy in measuring ICP values while assessing physiological parameters of the patient.
ICP measurement
Measured: 14 days following SAH
Secondary outcomes (2)
Incidence of Adverse events (AEs)
AE monitoring
Measured: 48 hours from the end of monitoring with the HS-1000
Rate of ear infections/irritations
Side effects
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 posted10 Mar 2016 (estimated)
- Study startMay 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospasm, IntracranialStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- E. Francois Aldrich, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704637
- Sponsor's protocol ID
- HS-026
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm
- ClinicalTrials.gov ID
- NCT02704637
- Acronym / sponsor ID
- HS-026
- Conditions
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- Keywords
- vasospasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, College Park
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Mar 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.
HeadSense (HS)-1000 device, a proprietary 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. The investigators hypothesize that the HS-1000 is capable of detecting vasospasm using the raw acoustic data derived from the noninvasive procedure.
Detailed description
The study will be an open-label, non-randomized, prospective study in patients with elevated risk of vasospasm after stabilizing the patient and treating the subarachnoid hemorrhage (SAH) to prevent further re-bleeds.
Each enrolled patient will be monitored with the HS-1000 device for a period of 10 minutes, occurring daily, after completion of surgery for SAH. Following admittance to the intensive care unit (ICU), patients will undergo routine monitoring as per standard of care. Non-invasive recordings of 10 minutes in duration with HS-1000 device will be completed daily for up to 14 days contingent on staff availability and the patient's clinical status. In the event a monitoring session is interrupted or postponed, another attempt to re-monitor will be made when the patient is able. Flexibility will granted in lieu of patient or study team unavailability thereby allowing recording to be neglected for any given day if absolutely necessary.
In the case the principle investigator (PI) or a member of the study team positively confirms vasospasm based on clinical assessment or follow-up care of the patient during the monitoring period, the patient will be recorded twice daily for up to a consecutive 14 days or for their duration in the ICU. The PI will determine the severity of vasospasm as per the vasospasm severity scale. Increased recording frequency will be implemented only for patients with vasospasm graded as asymptomatic moderate-to-severe or symptomatic mild-to-severe (i.e. those scoring 2a, 3a, 1s, 2s, or 3s).
Prior to the HS-1000 recording session, the front-end will be placed in the patient's ears and connected to the monitor. The acoustic signal propagates through the cranium, and attenuates during its propagation. The receiving sensor in the other headset picks up the acoustic signal. The receiving sensor converts the acoustical signal into a digital signal and transmits it back to the monitor.
Each recording session with the HS-1000 will last 10 consecutive minutes, if the patient's condition and clinical workflow permits. If required by the attending medical staff, the recording can be stopped and restarted at a later time during the day. The HS-1000 will be used as a seamless adjunctive, state-of-the-art, brain monitoring utility operating in parallel with standard care intensive neurological monitoring modalities. The non-invasive monitor will not replace or alter the standard care received by patients. Once all recordings are completed, the brain monitoring signals will be saved in the study's database.
Daily neurological checks and collection of all routine clinical and radiographic data as per standard of care will be gathered as the gold standard data for statistical comparison. Neurocognitive tests will be performed routinely every 8 hours by attending physicians to assess for neuro-deterioration and radiological (Computed tomographic angiography (CTA) and Digital subtraction angiography (DSA) components. Data collected from patients will be stripped of all personal health identifiers. Each subject will receive a unique identifying patient number linking the individual to their deidentified clinical data set. Only the medical staff attending to the patient's standard care will be knowledgeable to the identity of the subject.
Once data is collected, results of the HS-1000 recording sessions will be analyzed and correlated with deidentified supporting clinical/radiological data to assist in the identification of vasospasm-specific acoustic waveform patterns.
Deidentified supporting clinical data will consist of standard care intensive neurological monitoring procedures currently used to confirm clinical diagnosis of vasospasm, principally based on evidence of neuro deterioration:
- Computed tomographic angiography
- Digital subtraction angiography
- Neurocognitive clinical assessments
- Routine clinical data as per standard of care
Study workflow and HS-1000 recording sessions will be fully compatible with and will not alter the standard of care received by the patients in any way.
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-1000Each non-invasive recording session with the HS-1000 device will be done for 10 consecutive uninterrupted minutes. Patients will be recorded once daily for the duration of their time in ICU or for up to 14 days total. In the case the PI or a member of the study team positively confirms vasospasm based on clinical assessment or follow-up care during the monitoring period, the patient will be recorded twice daily for up to 14 consecutive days or for their duration in the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men and women at least 18 years of age inclusive at the time of hospital admission for stabilization and treatment of the SAH
- Subjects receiving intensive care neurological monitoring per standard care following treatment of SAH
- Subject or legal authorized representative is able and willing to comply with the requirements of the protocol
- Subject or legal authorized representative is able to understand and sign written informed consent to participate in the study
- Subject is expected to undergo standard care neurological intensive monitoring for a maximum of 14 days
Key exclusion criteria (11 listed)
- Subject with ear disease, ear trauma
- Subjects with dural defects, punctures
- Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
- Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
- Reported allergy or hypersensitivity to any of the test materials or contraindication to test materials
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-1000HeadSense (HS)-1000 device, a proprietary 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 | Device | HS-1000 recording |
Primary outcome
The HS-1000 will measure intracranial pressure readings from the patient which will then be used to generate vasospasm-specific acoustic waveform patterns.
Time frame: 14 days following SAH
Development of vasospasm-specific acoustic waveform patterns
To compare the HS-1000 ability and accuracy in detecting vasospasm by measuring ICP values compared to other standard of care vasospasm diagnostic modalities such as DSA and CTA.
Time frame: 14 days following SAH
Detection of vasospasm
To determine HS-1000's ability and accuracy in measuring ICP values while assessing physiological parameters of the patient.
Time frame: 14 days following SAH
ICP measurement
2 secondary outcomes
Incidence of Adverse events (AEs)
Time frame: 48 hours from the end of monitoring with the HS-1000
Rate of ear infections/irritations
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
E. Francois Aldrich, MD principal investigator
University of Maryland, College Park
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 Vasospasm, Intracranial and Subarachnoid Hemorrhage, run by HeadSense Medical at 1 site in United States.
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 8 inclusion and 11 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 1 site in United States. 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?
The HS-1000 will measure intracranial pressure readings from the patient which will then be used to generate vasospasm-specific acoustic waveform patterns. (time frame: 14 days following SAH). The study lists 3 primary outcomes in all. 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.