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Materials and methods.

T ranscranial laser therapy (TLT) is being tested as a therapy for patients with acute ischemic stroke. The NeuroThera Efficacy and Safety Trials, NEST-1 and NEST-2, demonstrated that TLT was safe. NEST-1, with 120 subjects, showed a significant clinical treatment benefit, whereas NEST-2, with 660 subjects, indicated a trend suggesting a possible benefit. Pooled analysis of these 2 trials showed that 41% of patients treated with TLT had a good outcome (modified Rankin Scale score ≤2) compared with 32% of those treated with sham (P=0.003; odds ratio, 1.67; 95% confidence interval , 1.19–2.35). 3 The exact mechanisms of the treatment effect are unknown. A leading concept is that infrared energy increases ATP in the brain and stimulates (or prevents) apoptotic cascades in mito-chondria. 4 The depth of brain penetration and putative therapeutic effect is also uncertain, but it is likely a few centimeters; therefore, superficial cerebral cortex is most likely to benefit from this intervention. We hypothesized that TLT would be most likely to have a measureable effect on cortical infarc-tion. We analyzed the NEST-2 data to determine whether TLT impacted cortical infarct volumes as well as total infarct volumes in subjects with probable cortical involvement. NEST-2 was a double-blind, sham-controlled, 1:1 randomized, clinical trial in which 660 patients were enrolled at 57 centers in 4 countries. Patients were eligible if they were 40 to 90 years of age, had a clinical diagnosis of acute ischemic stroke with a baseline National Institutes of Health Stroke Scale (NIHSS) score of 7 to 22, had no evidence of cerebral hemorrhage, had not received thrombolytic therapy, and provided informed consent. Initiation of treatment had to occur within 24 hours after stroke onset. Full inclusion and exclusion criteria are detailed in the primary report of this trial. 2 Subjects were randomly assigned to receive either TLT or sham. All subjects received standard medical management throughout the trial. Clinical assessments, including the NIHSS and modified Rankin Scale, were performed at baseline and day 90. Neuroimaging was performed at baseline and day 5 (±2). Total infarct volumes were measured quantitatively using Alice software (Hayden Image Processing Solutions). Total infarct volumes also were assessed semiquantita-tively using the Alberta Stroke Program Early CT Score (ASPECTS) 5 on all protocol-required computed tomography (CT) scans (or MRI, if clinically indicated) performed on day 5 (±2). All scans were interpreted for ASPECTS by 2 independent raters who were blinded to treatment …