HeadPulse Large Vessel Occlusion Validation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-16

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Acute ischemic stroke (AIS) is a treatable disease if patients can be transported and treated at stroke centers. MindRhythm, Inc (sponsor) has developed an investigational medical device that is designed for prehospital field use to differentiate the two major forms of acute ischemic stroke, namely Large Vessel Occlusion (LVO) stroke and non-large vessel occlusion stroke. The intended use is for paramedics to decide which destination hospital is best for the patient based on the device result. Large vessel occlusion stroke patients should be brought directly to comprehensive stroke centers which can perform thrombectomy, and non-large vessel occlusion stroke should be brought to primary stroke centers. Use of the device will save time getting the patient to thrombectomy and all others to intravenous thrombolytics or blood thinners that clear clots improves outcomes for all patients.

The Harmony 5000 device manufactured by MindRhythm has been tested in the pre-hospital environment, but because large vessel occlusion stroke is less common than non-large vessel occlusion stroke, the sponsor wants to obtain additional recordings from patients with large vessel occlusion to better refine their algorithms. Investigators will perform acute recordings on patients who arrive at the medical center who have computed tomography angiography studies showing the presence of large vessel occlusion stroke stroke, and on patients transferred to the angiography suite for thrombectomy. Recordings are performed in parallel to standard workflow of large vessel occlusion stroke patients so the research will not delay treatments.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Detection of hEad Pulse for Ischemic StrOke Verification Study

NCT05602740

Stroke, Acute

UNKNOWN

Head Pulse for Ischemic Stroke Detection

NCT03824496

Acute Ischemic Stroke

COMPLETED

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

NCT05122637

Acute Ischemic Stroke

COMPLETED NA

First-in-man Study of the Cerebrovascular Interventional Procedural Control System

NCT05972252

Acute Ischemic Stroke

UNKNOWN NA

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke

NCT05577351

Acute Ischemic Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Eligible participants will be 18 years of age plus with known large vessel occlusion who have been transferred to the emergency department. Recordings can be made just prior to the thrombectomy or within 2 hours of computed tomography angiography and no thrombectomy performed.

Participants will be excluded if they have an open wound on the scalp or are prisoners.

The MindRhythm Harmony headset will be placed on the subject (a total of 50 subjects) along with ECG leads and a 3 minute recording of the HeadPulse (cranial waveform) will be performed while the subject remains as still as possible. The data will then be transferred to MindRhythm for analysis and ultimate improvement of the diagnostic stroke algorithm.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult patient Known LVO (transferred or arrived at our ED) ICA-T, M1, M2 or Basilar Artery Recording can be made just prior to thrombectomy, or within 2 hours of CTA and no thrombectomy performed