Background: Ultralow-field portable MR devices (<0.1T) are emerging as novel tools for evaluating acute neurological conditions such as ischaemic and haemorrhagic stroke. The second-generation “Axana” 0.1T MR device, developed by Wellumio and weighing less than 100kg, uses Pulsed-Gradient Free Mapping technology and offers potential for point-of-care stroke imaging. This study assesses its feasibility in an acute stroke population.
Methods: This single-centre, prospective feasibility study aims to recruit 50 participants: 10 healthy controls and 40 stroke patients (30 ischaemic, 10 haemorrhagic) within 24 hours of stroke onset. Participants undergo standard 1.5–3T MRI (T1, T2, FLAIR, DWI, ADC) and two to three consecutive “Axana” scans within 72 hours of admission. A post-scan tolerability survey is completed, and central core lab evaluates image quality and agreement with conventional MRI. The primary outcome is the proportion of scans completed without artefact or device failure.
Results: Interim analysis includes 10 healthy controls and 8 stroke patients (7 ischaemic, 1 haemorrhagic). Median control age was 31.5 years (IQR 30–33), 75% female. No safety concerns reported. Of 15 Axana scans in healthy participants, 8 were rated as excellent, 4 as medium, and 3 as low quality—the latter attributed to user error and electromagnetic interference. High-signal quality Axana images (n=2, one ischaemic, one haemorrhagic) showed correct brain sector localisation on diffusion-weighted and T2-weight imaging respectively.
Conclusion: Early results support the safety and feasibility of the Axana 0.1T portable MR device for acute stroke imaging. Technical refinements, including electromagnetic interference suppression, are underway to optimise performance.