Portable EMVision emu™ helmet for detecting brain bleeding in people with suspected stroke

Multi-Center, Prospective, Consecutive, Paired Diagnosis, Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

This project will test a portable helmet-like EMVision emu™ scanner that uses radio waves to detect bleeding in the brain in adults who come to the emergency department with suspected stroke.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: EMVision Medical Devices Ltd (Research network)
• Locations: 4 sites (Jacksonville, Florida and 3 other locations)
• Trial ID: NCT06999122 on ClinicalTrials.gov

What this trial studies

This is an observational paired diagnostic accuracy effort comparing the EMVision emu™ helmet scanner to standard multi-modal CT and/or MRI imaging in adults with suspected stroke. Eligible patients are adults (≥22 years) presenting to participating emergency departments within 12 hours of symptom onset whose head size fits the device and where using the device will not delay care. Each participant receives the site’s standard CT/MRI workup while also undergoing the emu™ scan so results can be compared directly. The protocol ensures the investigational scan occurs in parallel with routine care and does not alter or delay standard treatment decisions.

Who should consider this trial

Good fit: Adults aged 22 or older who present to a participating emergency department within 12 hours of stroke symptom onset with suspected stroke, whose head fits the device and who can undergo CT or MRI without delaying care are ideal candidates.

Not a fit: Patients who received acute stroke treatment before initial imaging, those with contraindications to neuroimaging, implanted head/neck electrostimulation devices or cranial metallic implants, or whose head does not fit the scanner are unlikely to receive benefit from this device.

Why it matters

Potential benefit: If accurate, the emu™ device could enable faster and more widely available detection of intracranial hemorrhage, supporting quicker treatment decisions and potentially better outcomes.

How similar studies have performed: Early pilot and small diagnostic studies of radiofrequency-based head scanners have shown promising results but larger multi-center accuracy data remain limited and this device approach is still relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Adults ≥22 years of age
2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset
3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient
4. CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care
5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -

Exclusion Criteria:

1. Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
2. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
3. Presence of any implanted electro-stimulating devices in the head and neck
4. Presence of any metallic implants in the cranial vault or surrounding bones/tissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable)
5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
6. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
7. Unable to lie still for the duration of the scan
8. Pregnant or breastfeeding
9. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -

Where this trial is running

Jacksonville, Florida and 3 other locations

• Mayo Jacksonville — Jacksonville, Florida, United States (Not_yet_recruiting)
• UTHealth — Houston, Texas, United States (Not_yet_recruiting)
• Liverpool Hospital — Liverpool, New South Wales, Australia (Not_yet_recruiting)
• Royal Melbourne Hospital — Parkville, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Reade De Leacy, MBBS(Hons) FRANZCR — Associate Professor of Neurosurgery and Radiology Director of Neurointerventional Spine Site Director Cerebrovascular Services Mount Sinai Queens Co-director Neuroendovascular Surgery Fellowship Department of Neurosurgery Mount Sinai Health System
• Study coordinator: Christian Wight, PhD

Conditions Stroke; Hemorrhagic Stroke