NCT02704637

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 30, 2019

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 19, 2016

Last Update Submit

October 29, 2019

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Keywords

vasospasm

Outcome Measures

Primary Outcomes (3)

  • The HS-1000 will measure intracranial pressure readings from the patient which will then be used to generate vasospasm-specific acoustic waveform patterns.

    Development of vasospasm-specific acoustic waveform patterns

    14 days following SAH

  • 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.

    Detection of vasospasm

    14 days following SAH

  • To determine HS-1000's ability and accuracy in measuring ICP values while assessing physiological parameters of the patient.

    ICP measurement

    14 days following SAH

Secondary Outcomes (2)

  • Incidence of Adverse events (AEs)

    48 hours from the end of monitoring with the HS-1000

  • Rate of ear infections/irritations

    48 hours from the end of monitoring with the HS-1000

Other Outcomes (1)

  • 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.

    2 months after data collection complete

Study Arms (1)

HS-1000 recording

EXPERIMENTAL

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.

Device: HS-1000

Interventions

HS-1000DEVICE

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

HS-1000 recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult men and women at least 18 years of age inclusive at the time of hospital admission for stabilization and treatment of the SAH
  • Subjects receiving intensive care neurological monitoring per standard care following treatment of SAH
  • Subject or legal authorized representative is able and willing to comply with the requirements of the protocol
  • Subject or legal authorized representative is able to understand and sign written informed consent to participate in the study
  • Subject is expected to undergo standard care neurological intensive monitoring for a maximum of 14 days
  • Confirmed presence of a ruptured saccular aneurysm on angiography (catheter or CTA) and treated by neurosurgical clipping or endovascular coiling.
  • Patient must have a modified Fisher of II to IV.
  • The SAH should be between grades I-IV as defined by the World Federation of Neurological Surgery (WFNS).

You may not qualify if:

  • Subject with ear disease, ear trauma
  • Subjects with dural defects, punctures
  • Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
  • Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
  • Reported 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)
  • Patients who have a modified Fisher of 0 to I
  • Patients who have a WFNS of V
  • Presence of an intraventricular or intracerebral hemorrhage in absence of SAH or with only local, thin SAH
  • Angiographic vasospasm prior to aneurysm repair procedure, as documented by catheter angiogram or CTA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • E. Francois Aldrich, MD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Swanson

CONTACT

thomas@head-sense-med.com

Tricia Kwiatkowski

CONTACT

301-717-2657tricia@head-sense-med.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 10, 2016

Study Start

May 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 30, 2019

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)