Head Pulse for Ischemic Stroke Detection

NCT03824496 | Completed

• 1 other identifier: 17-21846
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Cranial accelerometry model

  Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects

  Through study completion, likely 2 years

Study Arms (1)

Suspected acute stroke

Any patient with suspected acute stroke triggering a "stroke code" and had a brain imaging angiogram

Diagnostic Test: Cranial Accelerometry Measurement

Interventions

Cranial Accelerometry Measurement DIAGNOSTIC_TEST

Measuring the HeadPulse using cranial accelerometry

Suspected acute stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been evaluated by a medical professional who feels the subject may be experiencing an acute stroke and has triggered the acute stroke algorithm within the medical center.

You may qualify if:

• Suspected acute stroke
• CTA or MRA performed

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 31, 2019
• Study Start: August 1, 2017
• Primary Completion: August 18, 2019
• Study Completion: August 18, 2019
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)