Head Pulse for Ischemic Stroke Detection

Overview

Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect LVO is needed. Using highly sensitive accelerometers, one can measure the "HeadPulse"- tiny forces exerted on the skull from the cardiac contraction. This study tests the hypothesis that LVO alters the HeadPulse characteristically. Analysis of these data along with the subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to create a model that can predict LVO status in suspect stroke subjects.

Full Title of Study: “Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2019

Detailed Description

Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers. Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers.

EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or absence of LVO based on recordings from a consecutive series of patients undergoing CTA for suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during LVO.

Interventions

  • Diagnostic Test: Cranial Accelerometry Measurement
    • Measuring the HeadPulse using cranial accelerometry

Arms, Groups and Cohorts

  • Suspected acute stroke
    • Any patient with suspected acute stroke triggering a “stroke code” and had a brain imaging angiogram

Clinical Trial Outcome Measures

Primary Measures

  • Cranial accelerometry model
    • Time Frame: Through study completion, likely 2 years
    • Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects

Participating in This Clinical Trial

Inclusion Criteria

  • Suspected acute stroke
  • CTA or MRA performed

Exclusion Criteria

  • Any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wade Smith, Professor of Neurology – University of California, San Francisco
  • Overall Contact(s)
    • Dominca Randazzo, 415-206-8094, dominica.randazzo@ucsf.edu

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