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(Stroke. 2009;40:1359.)
© 2009 American Heart Association, Inc.

Original Contributions

Effectiveness and Safety of Transcranial Laser Therapy for Acute Ischemic Stroke

Justin A. Zivin, MD, PhD; Gregory W. Albers, MD; Natan Bornstein, MD; Thomas Chippendale, MD, PhD; Bjorn Dahlof, MD, PhD; Thomas Devlin, MD, PhD; Marc Fisher, MD; Werner Hacke, MD, PhD; William Holt, DO; Sanja Ilic, MD; Scott Kasner, MD; Robert Lew, PhD; Marshall Nash, MD; Julio Perez, MD; Marilyn Rymer, MD; Peter Schellinger, MD, PhD; Dietmar Schneider, MD; Stefan Schwab, MD; Roland Veltkamp, MD; Michael Walker, PhD; Jackson Streeter, MD for the NEST-2 Investigators

From the Department of Neurosciences (J.Z.), University of California San Diego, La Jolla, Calif; Stanford Stroke Center (G.A.), Stanford University Medical Center, Palo Alto, Calif; Tel Aviv Medical Center (N.B.), Tel Aviv, Israel; Scripps Hospital (T.C.), Encinitas, Calif; Sahlgrenska University Hospital (B.D.), Gothenburg, Sweden; Erlanger Health System (T.D.), Chattanooga, Tenn; University of Massachusetts Medical School (M.F.), Worcester, Mass; Department of Neurology (W.H.), Universität Heidelberg, Heidelberg, Germany; Fawcett Memorial Hospital (W.A.H.), Port Charlotte, Fla; Triage Wireless, Inc (S.I.), San Diego, Calif; the Department of Neurology (S.E.K.), University of Pennsylvania School of Medicine, Philadelphia, Pa; Boston University (R.L.), Boston, Mass; DeKalb Neurology Associates (M.N.), Decatur, Ga; Hospital Nacional Dos de Mayo (J.P.), Lima, Peru; St. Luke’s Health System (M.R.), Kansas City, Mo; Universitätsklinikum Erlangen (P.S.), Erlangen, Germany; the Department of Neurology (D.S.), Universität Leipzig, Leipzig, Germany; Universitätsklinikum Erlangen (S.S.), Erlangen, Germany; Department of Neurology (R.V.), Universität Heidelberg, Heidelberg, Germany; Stanford Center for Biomedical Informatics Research (M.W.), Stanford School of Medicine, Palo Alto, Calif; and PhotoThera, Inc (J.S.), Carlsbad, Calif.

Correspondence to Justin Zivin, MD, PhD, Neurology Service (127), University of California San Diego, 3350 La Jolla Village Drive, San Diego CA 92161, USA. E-mail jzivin{at}ucsd.edu

Background and Purpose— We 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.

Methods— This 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.

Results— We 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.

Conclusions— TLT 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.

Key Words: acute stroke • infrared laser therapy • clinical trial