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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 -

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 -

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting
• Mayo Jacksonville
  Jacksonville, Florida, United States Recruiting
• Mount Sinai West
  New York, New York, United States Recruiting
• Mount Sinai Health System
  New York, New York, United States Recruiting
• Memorial Hermann Memorial City Medical Center
  Houston, Texas, United States Recruiting
• UTHealth
  Houston, Texas, United States 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
• Email: cwight@emvision.com.au
• Phone: 61 (0) 490 109 797

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.