title: Effectiveness and safety of transcranial laser therapy for acute ischemic stroke.
abstract: OBJECTIVE
  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.
authors.affiliation: Department of Neurosciences, University of California San Diego, San Diego, CA 92161, USA. jzivin@ucsd.edu
authors.forename: Justin A
authors.initials: JA
authors.lastname: Zivin
authors.forename: Gregory W
authors.initials: GW
authors.lastname: Albers
authors.forename: Natan
authors.initials: N
authors.lastname: Bornstein
authors.forename: Thomas
authors.initials: T
authors.lastname: Chippendale
authors.forename: Bjorn
authors.initials: B
authors.lastname: Dahlof
authors.forename: Thomas
authors.initials: T
authors.lastname: Devlin
authors.forename: Marc
authors.initials: M
authors.lastname: Fisher
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
authors.forename: William
authors.initials: W
authors.lastname: Holt
authors.forename: Sanja
authors.initials: S
authors.lastname: Ilic
authors.forename: Scott
authors.initials: S
authors.lastname: Kasner
authors.forename: Robert
authors.initials: R
authors.lastname: Lew
authors.forename: Marshall
authors.initials: M
authors.lastname: Nash
authors.forename: Julio
authors.initials: J
authors.lastname: Perez
authors.forename: Marilyn
authors.initials: M
authors.lastname: Rymer
authors.forename: Peter
authors.initials: P
authors.lastname: Schellinger
authors.forename: Dietmar
authors.initials: D
authors.lastname: Schneider
authors.forename: Stefan
authors.initials: S
authors.lastname: Schwab
authors.forename: Roland
authors.initials: R
authors.lastname: Veltkamp
authors.forename: Michael
authors.initials: M
authors.lastname: Walker
authors.forename: Jackson
authors.initials: J
authors.lastname: Streeter
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D007259:Infrared Rays; D028022:Low-Level Light Therapy / Q000009:adverse effects* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D020521:Stroke / Q000401:mortality / Q000532:radiotherapy*; D016896:Treatment Outcome