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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02775136|
Recruitment Status : Unknown
Verified December 2016 by HeadSense Medical.
Recruitment status was: Recruiting
First Posted : May 17, 2016
Last Update Posted : December 23, 2016
|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)|
|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|
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
- 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 ]
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 Swansonfirstname.lastname@example.org|
|Contact: Dana Hromyakemail@example.com|
|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|
|Contact: Rudolf Rammensee 09131 85-33001 firstname.lastname@example.org|
|Principal Investigator: Rudolf Rammensee|
|Gottingen, Germany, 37075|
|Contact: Christian von der Brelie, Dr. email@example.com|
|Principal Investigator: Christian von der Brelie, Dr.|
|Contact: Oliver Ganslandt, Prof. 0711 278-33700 firstname.lastname@example.org|
|Principal Investigator: Oliver Ganslandt, Prof.|
|Principal Investigator:||Oliver Ganslandt, Prof.||Klinikum Stuttgart|