No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
300 (estimated)
Sponsor
EMVision Medical Devices Ltd · Research network
Who this trial is looking for
This trial is looking for adults suspected of having a stroke. Participants will undergo a scan with a new device designed to quickly detect bleeding in the brain.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult aged 22 or older
I have symptoms that suggest a stroke
My symptoms started within the last 24 hours
I can have a CT or MRI scan after the EMVision scan
My head size is suitable for the EMVision scan
You may not be able to join if
I have received treatment for a stroke before the scans
I was in the hospital for a neurological condition before my stroke symptoms
I was in intensive care before my stroke symptoms
I have a condition that makes neuroimaging unsafe
I have any electro-stimulating devices in my head or neck
I have metallic implants in my skull or nearby areas
I cannot wear the EMVision device due to scalp issues or injuries
I am pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Comp…
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.
Trial Locations
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Eligibility Criteria
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 …
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 -
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