An interventional study of HS-1000 in Stroke, sponsored by HeadSense Medical. Completed at 1 site in Armenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by HeadSense Medical · Not applicable, Interventional, and Diagnostic
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.
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.
HeadSense Medical is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Number of HS recordings that correlate with clinical findings in the diagnosis of stroke
Time frame: 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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