An Evaluation of a Non-invasive Brain Monitor

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Brief Title

An Evaluation of a Non-invasive Brain Monitor

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

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.
    

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


Primary Outcome

Number of recordings that correlate to neuropathology

Secondary Outcome

 Incidence of adverse events

Condition

Brain Injuries

Intervention

HS-1000 recording

Study Arms / Comparison Groups

 HS-1000 recording
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

160

Start Date

October 2014

Completion Date

December 2017

Primary Completion Date

June 2017

Eligibility Criteria

        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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Oliver Ganslandt, Prof., , [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02775136

Organization ID

HS-011


Responsible Party

Sponsor

Study Sponsor

HeadSense Medical

Collaborators

 Klinikum Stuttgart

Study Sponsor

Oliver Ganslandt, Prof., Principal Investigator, Klinikum Stuttgart


Verification Date

December 2016