An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care

Study Overview
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Brief Summary
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The HS-1000 device, an investigational intracranial monitoring device, has the potential to safely and quickly diagnose and assess stroke (and potentially other neurologic conditions) with minimal discomfort to patients. HS-1000 has the capability to establish cerebral hemodynamic measurements in suspected stroke within minutes, assist with appropriate management of stroke, and also provide an objective diagnostic tool for clinicians to monitor recovery.

Detailed Description
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A prospective study will be conducted on patients with suspected stroke and/or acute neurologic changes treated at the Armenia Republican Medical Center. Male and Female patients over the age of 18 will be eligible for enrollment into the study. Eligible patients or their legally authorized representative (LAR) will be approached for consent to participate in the study. An initial recording session using the HeadSense HS-1000 device will be obtained upon admission to the hospital. During the admission, 2-4 additional recording sessions with the HS-1000 will be completed. The end-point of the study is to collect up to 30-minute recording with up to 5 sessions of adequate quality for analysis from up to 200 subjects. This data will be correlated with clinical findings obtained during the patient's diagnosis and treatment course. An ease-of-use questionnaire will be administered to the HS-1000 device operator(s) to obtain information regarding the function and workflow aspects of using the HS-1000 in an acute setting to improve assessment, diagnosis and treatment after stroke. The data obtained from the HS-1000 recordings will be analyzed to establish specific waveform patterns correlated with brain physiology after stroke.

Official Title
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An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care

Conditions
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Stroke

Intervention / Treatment
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* Device: HS-1000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects, > 18 years of age Subjects with suspected stroke and/or acute neurologic changes admitted to Armenia Republican Medical Center Subject or legally authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol Subject or legally 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS-1000 recording<br>The recording session should be performed in a quiet environment with no disturbance to the patient for a total of up to 60 minutes. | Device: HS-1000<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HS recordings that correlate with clinical findings in the diagnosis of stroke |  | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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noninvasive monitoring