Clinical trial NCT02772484: An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
Official title: An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: noninvasive monitoring
Lead sponsor: HeadSense Medical
Sponsor class: INDUSTRY
Collaborators: name: State Medical Center, Republic of Armenia
First posted: 2016-05-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of HS recordings that correlate with clinical findings in the diagnosis of stroke
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: State Medical Center, Republic of Armenia
Study officials:
affiliation: State Medical Center, Republic of Armenia
name: Ara Ghazaryan
role: PRINCIPAL_INVESTIGATOR
References: