An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care
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|ClinicalTrials.gov Identifier: NCT02772484|
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : December 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: HS-1000||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Routine Care|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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.
- Number of HS recordings that correlate with clinical findings in the diagnosis of stroke [ Time Frame: 60 minutes ]
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): NCT02772484
|State Medical Center, Republic of Armenia|
|Principal Investigator:||Ara Ghazaryan||State Medical Center, Republic of Armenia|