An Evaluation of a Non-invasive Brain Monitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02775136
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : December 23, 2016
Klinikum Stuttgart
Klinikum Darmstadt
University Medical Center Goettingen
Information provided by (Responsible Party):
HeadSense Medical

Brief 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. Investigators hypothesis that the HS-1000 is capable of detecting and monitoring various neuropathologies, using the acoustic raw data derived from the noninvasive procedure.

Condition or disease Intervention/treatment
Brain Injuries Subarachnoid Hemorrhage Vasospasm, Intracranial Hydrocephalus Brain Neoplasms Device: HS-1000 recording

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:

  1. Patients undergoing Invasive ICP monitoring
  2. 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:

  1. 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.
  2. 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Device: HS-1000 recording

Primary Outcome Measures :
  1. Number of recordings that correlate to neuropathology [ Time Frame: up to 1 hour ]
    Demonstrate the HS-1000 performance and accuracy in brain monitoring

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 48 hours from the end of monitoring with the HS-1000 ]
  2. 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 ]

Information from the National Library of Medicine

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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:

  1. Adult men and women subjects, aged 18 years old and over at screening visit
  2. Subjects with neuropathology that the principal investigator considers including in this study.
  3. Survival expectancy greater than 72 hours
  4. Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
  5. Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study

Exclusion Criteria:

  1. Local ear infection
  2. Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
  3. For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
  4. Subarachnoid hemorrhage (SAH), Fisher Grade 4
  5. 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)
  6. 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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02775136

Contact: Thomas Swanson 410-245-9782
Contact: Dana Hromyak 216-526-8534

Klinikum Darmstadt Recruiting
Darmstadt, Germany, 64283
Contact: Rainer Kollmar, Prof.    06151 - 107 4501   
Principal Investigator: Rainer Kollmar, Prof.         
Sub-Investigator: Ilia Aroyo, Dr.         
University Hospital Erlangen Recruiting
Erlangen, Germany
Contact: Rudolf Rammensee    09131 85-33001   
Principal Investigator: Rudolf Rammensee         
Universitätsklinik Göttingen Recruiting
Gottingen, Germany, 37075
Contact: Christian von der Brelie, Dr.   
Principal Investigator: Christian von der Brelie, Dr.         
Klinikum Stuttgart Recruiting
Stuttgart, Germany
Contact: Oliver Ganslandt, Prof.    0711 278-33700   
Principal Investigator: Oliver Ganslandt, Prof.         
Sponsors and Collaborators
HeadSense Medical
Klinikum Stuttgart
Klinikum Darmstadt
University Medical Center Goettingen
Principal Investigator: Oliver Ganslandt, Prof. Klinikum Stuttgart

Responsible Party: HeadSense Medical 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
Subarachnoid Hemorrhage
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