Feasibility Assessment of the Wellumio 'Axana' 0.1T Portable MRI Device

This study aims to identify if the Wellumio 'Axana' device, a portable 0.1T MRI, is feasible, safe and reliable for use in the hospital setting.

Primary Objective

• To assess the safety (adverse events) and feasibility (ability to acquire a scan, in a timely manner without technical fault) of the Wellumio 'Axana' device in the hospital setting with healthy controls and patients.

Secondary Objective

• Assess usability of the Axana device.
• Acquire physiological data from healthy controls and hospital patients with the 'Axana' device, and hospital MRI scanners.
• Investigate the repeatability and reproducibility of scans acquired with the Axana device within and between participants.

Inclusion criteria

Healthy Participants:

• Adults aged 18 years or older.
• Able to undergo an in-hospital MRI scan.
• Able to provide informed consent.
• Head size considered suitable for scanning with the Wellumio Axana brain scanner.

Hospital Patients:

• Adults aged 18 years or older.
• Presenting to hospital with an acute neurological deficit suspected to be stroke within 24 hours of symptom onset.
• Clinical and radiological diagnosis of stroke, including ischemic stroke, haemorrhagic stroke, or subarachnoid haemorrhage.
• Able to undergo an in-hospital MRI scan.
• Up to 72 hours post-acute stroke.
• Able to provide written informed consent or, where this is not possible, informed consent provided by a legally authorised representative.
• Head size considered suitable for scanning with the Wellumio Axana brain scanner.

Exclusion criteria

General:

• Pregnant or breastfeeding.
• Contraindication to neuroimaging, including any condition that prohibits MRI.
• Presence of an implanted electro-stimulating device in the head or neck.
• Presence of a large metallic craniofacial implant, such as a bone fixation plate or mesh. Small metallic objects, such as aneurysm coils, are acceptable.
• Presence of an intracranial pressure monitor or another similar sensor that may compromise placement of the investigational device.
• Inability to wear the investigational device, including because of scalp skin lesions or previous intracranial surgery.
• Unable to lie still for the duration of the scan.
• Any other condition or symptom that, in the investigator's judgement, prevents participation in the study.
• Unable to provide informed consent and, where applicable, consent cannot be obtained from a legally authorised representative.

Healthy Participants:

• History of a neurological condition, including brain tumour, previous stroke, or neurological trauma.
• Post-study MRI findings indicating a brain condition associated with structural changes.