Head Pulse for Ischemic Stroke Detection

Acute Ischemic Stroke Clinical Trial

— EPISODE  

Official title:

Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824496
• Other study ID #: 17-21846
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: August 18, 2019

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 18, 2019
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cranial accelerometry model	Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects	Through study completion, likely 2 years