An Evaluation of a Non-invasive Brain Monitor
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ClinicalTrials.gov Identifier: NCT02775136 |
Recruitment Status
:
Recruiting
First Posted
: May 17, 2016
Last Update Posted
: December 23, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Injuries Subarachnoid Hemorrhage Vasospasm, Intracranial Hydrocephalus Brain Neoplasms | Device: HS-1000 recording | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Study Start Date : | October 2014 |
Estimated Primary Completion Date : | June 2017 |
Estimated Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: HS-1000 recording
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.
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Device: HS-1000 recording |
- Number of recordings that correlate to neuropathology [ Time Frame: up to 1 hour ]Demonstrate the HS-1000 performance and accuracy in brain monitoring
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775136
Contact: Thomas Swanson | 410-245-9782 | thomas@head-sense-med.com | |
Contact: Dana Hromyak | 216-526-8534 | dana@head-sense-med.com |
Germany | |
Klinikum Darmstadt | Recruiting |
Darmstadt, Germany, 64283 | |
Contact: Rainer Kollmar, Prof. 06151 - 107 4501 Rainer.Kollmar@mail.klinikum-darmstadt.de | |
Principal Investigator: Rainer Kollmar, Prof. | |
Sub-Investigator: Ilia Aroyo, Dr. | |
University Hospital Erlangen | Recruiting |
Erlangen, Germany | |
Contact: Rudolf Rammensee 09131 85-33001 rudolf.rammensee@uk-erlangen.de | |
Principal Investigator: Rudolf Rammensee | |
Universitätsklinik Göttingen | Recruiting |
Gottingen, Germany, 37075 | |
Contact: Christian von der Brelie, Dr. cvdb@gmx.net | |
Principal Investigator: Christian von der Brelie, Dr. | |
Klinikum Stuttgart | Recruiting |
Stuttgart, Germany | |
Contact: Oliver Ganslandt, Prof. 0711 278-33700 o.ganslandt@klinikum-stuttgart.de | |
Principal Investigator: Oliver Ganslandt, Prof. |
Principal Investigator: | Oliver Ganslandt, Prof. | Klinikum Stuttgart |
Responsible Party: | HeadSense Medical |
ClinicalTrials.gov Identifier: | NCT02775136 History of Changes |
Other Study ID Numbers: |
HS-011 |
First Posted: | May 17, 2016 Key Record Dates |
Last Update Posted: | December 23, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by HeadSense Medical:
brain injuries neurological monitoring |
Additional relevant MeSH terms:
Brain Injuries Hemorrhage Subarachnoid Hemorrhage Hydrocephalus Brain Neoplasms Vasospasm, Intracranial Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms |