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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: HS-1000

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia
    • State Medical Center, Republic of Armenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-1000 recording; 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HeadSense Medical
• Collaborators: State Medical Center, Republic of Armenia
• Investigators: Principal Investigator: Ara Ghazaryan, State Medical Center, Republic of Armenia

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 13, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: noninvasive monitoring
• Other Study ID Numbers: HS-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO