Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

ID#: NCT06999122

Age: 22 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: March 26, 2025

End Date: November 28, 2026

Contact Information:
Christian Wight, PhD
61 (0) 490 109 797
Sadie Burnham
7742078910
Summary: The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.
Eligibility:

Inclusion Criteria:

1. Adults ≥22 years of age

2. Observable acute neurological deficit suspected to be stroke and within 24 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 per standard of care

5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner

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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. In-patient for a neurological condition prior to suspected stroke onset

3. In-patient in intensive care unit prior to suspected stroke onset

4. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography

5. Presence of any implanted electro-stimulating devices in the head and neck

6. 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)

7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device

8. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)

9. Unable to lie still for the duration of the scan

10. Pregnant or breastfeeding

11. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -
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