Abstract
BackgroundVoxel-based algorithms using acute multiparametric-MRI data have been shown to accurately predict tissue outcome after stroke. We explored the potential of MRI-based predictive algorithms to objectively assess the effects of normobaric oxygen therapy (NBO), an investigational stroke treatment, using data from a pilot study of NBO in acute stroke.MethodsThe pilot study of NBO enrolled 11 patients randomized to NBO administered for 8 hours, and 8 Control patients who received room-air. Serial MRIs were obtained at admission, during gas therapy, post-therapy, and pre-discharge. Diffusion/perfusion MRI data acquired at admission (pre-therapy) was used in generalized linear models to predict the risk of lesion growth at subsequent time points for both treatment scenarios: NBO or Control.ResultsLesion volume sizes 'during NBO therapy' predicted by Control-models were significantly larger (P = 0.007) than those predicted by NBO models, suggesting that ischemic lesion growth is attenuated during NBO treatment. No significant difference was found between the predicted lesion volumes at later time-points. NBO-treated patients, despite showing larger lesion volumes on Control-models than NBO-models, tended to have reduced lesion growth.ConclusionsThis study shows that NBO has therapeutic potential in acute ischemic stroke, and demonstrates the feasibility of using MRI-based algorithms to evaluate novel treatments in early-phase clinical trials.
Highlights
Voxel-based algorithms using acute multiparametric-Magnetic resonance imaging (MRI) data have been shown to accurately predict tissue outcome after stroke
MRI voxel-based predictive algorithms based on admission MRI datasets including diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI), have been shown to accurately predict tissue outcomes in acute stroke patients [1,2] and animal stroke models [3,4,5,6]
We extend our prior research by developing models under treatment and control conditions in order to predict tissue outcome after normobaric oxygen therapy (NBO), a promising investigational acute stroke treatment [8,9,10,11,12,13,14,15,16,17]
Summary
Voxel-based algorithms using acute multiparametric-MRI data have been shown to accurately predict tissue outcome after stroke. We explored the potential of MRI-based predictive algorithms to objectively assess the effects of normobaric oxygen therapy (NBO), an investigational stroke treatment, using data from a pilot study of NBO in acute stroke. In the pilot study [18], NBO transiently improved clinical deficits and reduced DWI lesions in stroke patients with mismatches in lesion volumes on DWI and PWI. These effects were most evident during therapy, suggesting that NBO may slow down the process of ischemic necrosis and be a simple strategy to extend the narrow time window for stroke thrombolysis. We postulated that differences between the expected outcomes of these models will objectively validate prior observations and provide insights into NBO’s mechanisms
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