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HS-1000 recording for Intracranial Vasospasm

N/A
Waitlist Available
Led By E. Francois Aldrich, MD
Research Sponsored by HeadSense Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months after data collection complete
Awards & highlights

Study Summary

HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians. The investigators hypothesize that the HS-1000 is capable of detecting vasospasm using the raw acoustic data derived from the noninvasive procedure.

Eligible Conditions
  • Intracranial Vasospasm
  • Subarachnoid Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months after data collection complete
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months after data collection complete for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The HS-1000 will measure intracranial pressure readings from the patient which will then be used to generate vasospasm-specific acoustic waveform patterns.
To compare the HS-1000 ability and accuracy in detecting vasospasm by measuring ICP values compared to other standard of care vasospasm diagnostic modalities such as DSA and CTA.
To determine HS-1000's ability and accuracy in measuring ICP values while assessing physiological parameters of the patient.
Secondary outcome measures
Incidence of Adverse events (AEs)
Rate of ear infections/irritations
Other outcome measures
To evaluate the ergonomic and functional aspects of using the HS-1000 by having the operators of the device complete a brief 5 question survey about the ease or difficulty in using the device.

Trial Design

1Treatment groups
Experimental Treatment
Group I: HS-1000 recordingExperimental Treatment1 Intervention
Each non-invasive recording session with the HS-1000 device will be done for 10 consecutive uninterrupted minutes. Patients will be recorded once daily for the duration of their time in ICU or for up to 14 days total. In the case the PI or a member of the study team positively confirms vasospasm based on clinical assessment or follow-up care during the monitoring period, the patient will be recorded twice daily for up to 14 consecutive days or for their duration in the ICU.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HS-1000
2016
N/A
~80

Find a Location

Who is running the clinical trial?

HeadSense MedicalLead Sponsor
11 Previous Clinical Trials
676 Total Patients Enrolled
University of Maryland, College ParkOTHER
155 Previous Clinical Trials
45,640 Total Patients Enrolled
E. Francois Aldrich, MDPrincipal InvestigatorUniversity of Maryland, College Park

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
An Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm
2017. "An Evaluation of Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02704637.
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