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Head Pulse for Ischemic Stroke Detection

Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03824496
Acronym
EPISODE
Enrollment
42
Registered
2019-01-31
Start date
2017-08-01
Completion date
2019-08-18
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Brief summary

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.

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_TESTCranial Accelerometry Measurement

Measuring the HeadPulse using cranial accelerometry

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cranial accelerometry modelThrough study completion, likely 2 yearsDifference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026