None listed
Conditions
Brief summary
- Neuroimaging for stroke diagnosis is limited to many Australians. - This study is a first-in-human study of a portable low field magnetic resonance imaging device named 'Axana' to diagnose stroke, ultimately in the pre-hospital and emergency department setting. - This study aims to test the feasibility and safety of this device in a stroke and healthy cohort in the hospital setting.
Interventions
Use of a portable (100kg) ultra-low-field (0.1 Tesla) magnetic resonance device for the diagnosis of stroke and differentiation of stroke type
- The 'Axana' device is a portable ~100kg ultra-low-field magnetic resonance device that utilises a fixed magnet Aubert ring that is optimised to provide brain coverage. This magnet ring creates a non-homogenous B0 magnetic field, and when coupled with radio frequency generators at specific points around the periphery, allow for a quadrant based spatial i
Use of a portable (100kg) ultra-low-field (0.1 Tesla) magnetic resonance device for the diagnosis of stroke and differentiation of stroke type - The 'Axana' device is a portable ~100kg ultra-low-field magnetic resonance device that utilises a fixed magnet Aubert ring that is optimised to provide brain coverage. This magnet ring creates a non-homogenous B0 magnetic field, and when coupled with radio frequency generators at specific points around the periphery, allow for a quadrant based spatial information for diagnosis of stroke. This device is low noise, and low energy requiring due to not requiring pulse gradient coils or active cooling. - This device will be operated by one to two research nurses who have undergone training with the sponsor for operation of the device, supported by a technical support line hosted by the Wellumio, Ltd company. - The face to face training was undertaken by all primary participating research nurses with a train-the-trainer model for other participating research team members via face-to-face and supervised operation of the device. The initial training was undertaken by the Wellumio, Ltd company representatives 1-2 week prior to commencement of the trial. - The 'Axana' device scan will be completed two consecutive times for participants with stroke, and 3 scans (two consecutive, one calibration, then the final scan) for healthy participants. These last approximately 9-minutes per scan. - During scanning, all included participants have information obtained for head position, movement, and tolerance that is recorded to determine the potential fidelity of the final imaging outcome. Ongoing optimisation of the headboard, workflow, and patient positioning will be undertaken during the study to improve the patient experience.
Sponsors
Wellumio, Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy participants 1. Adults greater than or equal to 18 years of age. 2. The participant is able to have an in-hospital MRI scan. 3. Ability to provide informed consent. 4. Head size deemed suitable for scanning with the Wellumio ‘Axana’ brain scanner. Hospital patients 1. Adults greater than or equal to 18 years of age. 2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 24 hours of symptom onset. 3. Clinical and radiological diagnosis of a stroke (Ischaemic and intra-cranial haemorrhagic including subarachnoid and Subdural haematomas). 4. The patient is able to have an in-hospital MRI scan. 5. The participant is up to 72 hours post-acute stroke. 6. Consent: a. Ability to provide informed consent. Participants will provide written informed consent. b. Where a) is not possible, consent from a legal authorized representative will be obtained. 7. Head size deemed suitable for scanning with the Wellumio ‘Axana’ brain scanner.
Exclusion criteria
General - Inability to provide consent. - Pregnant or breastfeeding. - Contraindication to neuroimaging, such conditions that prohibits MRI. - Presence of any implanted electro-stimulating devices in the head and neck. - Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc (Note that small metallic objects, such an aneurysm coils etc, are acceptable). - Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device. - Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc). - Unable to lie still for the duration of the scan. - Any other condition or symptoms preventing the participant from entering the study, according to the investigator ´s judgment. Healthy Controls - History of neurological conditions (i.e. tumour, prior stroke, trauma etc). - Post study MRI findings of brain conditions causing structural changes.
Outcome results
None listed