An Evaluation of a Non-invasive Brain Monitor

Not Applicable

• Conditions: Brain Injuries; Hydrocephalus; Vasospasm, Intracranial; Subarachnoid Hemorrhage; Brain Neoplasms
• Interventions: Device: HS-1000 recording

• Registration Number: NCT02775136
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-17
• Status Verified: 2016-12
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HS-1000 recording	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.

Primary Outcome Measures

Name	Time	Method
Number of recordings that correlate to neuropathology	up to 1 hour	Demonstrate the HS-1000 performance and accuracy in brain monitoring

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	48 hours from the end of monitoring with the HS-1000
Rate of ear infections/irritations graded by none/mild/moderate and severe	48 hours from the end of monitoring with the HS-1000

Trial Locations

Locations (4)

Klinikum Darmstadt; 🇩🇪 Darmstadt, Germany

Universitätsklinik Göttingen; 🇩🇪 Gottingen, Germany

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany