• Justin A Zivin, Gregory W Albers, Natan Bornstein, Thomas Chippendale, Bjorn Dahlof, Thomas Devlin, Marc Fisher, Werner Hacke, William Holt, Sanja Ilic, Scott Kasner, Robert Lew, Marshall Nash, Julio Perez, Marilyn Rymer, Peter Schellinger, Dietmar Schneider, Stefan Schwab, Roland Veltkamp, Michael Walker, Jackson Streeter, and NeuroThera Effectiveness and Safety Trial-2 Investigators.
• Department of Neurosciences, University of California San Diego, San Diego, CA 92161, USA. jzivin@ucsd.edu
• Stroke. 2009 Apr 1; 40 (4): 1359-64.

Background And PurposeWe hypothesized that transcranial laser therapy (TLT) can use near-infrared laser technology to treat acute ischemic stroke. The NeuroThera Effectiveness and Safety Trial-2 (NEST-2) tested the safety and efficacy of TLT in acute ischemic stroke.MethodsThis double-blind, randomized study compared TLT treatment to sham control. Patients receiving tissue plasminogen activator and patients with evidence of hemorrhagic infarct were excluded. The primary efficacy end point was a favorable 90-day score of 0 to 2 assessed by the modified Rankin Scale. Other 90-day end points included the overall shift in modified Rankin Scale and assessments of change in the National Institutes of Health Stroke Scale score.ResultsWe randomized 660 patients: 331 received TLT and 327 received sham; 120 (36.3%) in the TLT group achieved favorable outcome versus 101 (30.9%), in the sham group (P=0.094), odds ratio 1.38 (95% CI, 0.95 to 2.00). Comparable results were seen for the other outcome measures. Although no prespecified test achieved significance, a post hoc analysis of patients with a baseline National Institutes of Health Stroke Scale score of <16 showed a favorable outcome at 90 days on the primary end point (P<0.044). Mortality rates and serious adverse events did not differ between groups with 17.5% and 17.4% mortality, 37.8% and 41.8% serious adverse events for TLT and sham, respectively.ConclusionsTLT within 24 hours from stroke onset demonstrated safety but did not meet formal statistical significance for efficacy. However, all predefined analyses showed a favorable trend, consistent with the previous clinical trial (NEST-1). Both studies indicate that mortality and adverse event rates were not adversely affected by TLT. A definitive trial with refined baseline National Institutes of Health Stroke Scale exclusion criteria is planned.

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