An Early Feasibility Study to Obtain Imaging Data from Participants witha Diagnosed Stroke to Refine the Algorithm for the EMVision Brain Scanner
- Conditions
- Stroke diagnosisStroke - Haemorrhagic
- Registration Number
- ACTRN12619001684112
- Lead Sponsor
- EMvision Medical Devices Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 30
1.Adults >=18 years of age.
2.Admitted to hospital with new neurological signs and confirmed diagnosis of stroke supported by conventional brain imaging.
3.Ability to provide informed consent. Participants will provide written informed consent. Where this is not possible, surrogate consent will be obtained.
4.Ability to adhere to study visit schedule and other protocol requirements.
5.Confirmed diagnosis of stroke within 72 hours of admission.
6.Head size deemed suitable for scanning with the EMVision brain scanner.
1.Experiences seizures from onset of stroke, or known history of seizure episodes.
2.Has injury or known medical condition on the head that would not allow the placement of EMVision brain scanner.
3.Is unable to lie still for the duration of the scan.
4.Is not a suitable candidate according to the assessing investigator.
5.Has any metal implants in the head or neck for example stents, aneurism clips, surgical clips, pressure monitors and drains.
6.Is known to be pregnant or lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Per protocol, this is a only a data gathering study with the primary outcome being the acquisition of a dataset of stroke patient scans which will improve the understanding of stroke on electromagnetic scattering effects in the brain. <br><br>There is no diagnostic nor interventional outcome for this initial study.<br><br>The dataset will enable the algorithms to be developed leading to image acquisition in the future. This will then lead to the next efficacy study.[The Research team estimates that 30 datasets from stroke patients will provide sufficient information to meet the primary endpoint. The time to achieve this is approx. 6 months.]
- Secondary Outcome Measures
Name Time Method