Effectiveness and safety of transcranial laser therapy for acute ischemic stroke.
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.
Zivin
Justin A
JA
Department of Neurosciences, University of California San Diego, San Diego, CA 92161, USA. jzivin@ucsd.edu
Albers
Gregory W
GW
Bornstein
Natan
N
Chippendale
Thomas
T
Dahlof
Bjorn
B
Devlin
Thomas
T
Fisher
Marc
M
Hacke
Werner
W
Holt
William
W
Ilic
Sanja
S
Kasner
Scott
S
Lew
Robert
R
Nash
Marshall
M
Perez
Julio
J
Rymer
Marilyn
M
Schellinger
Peter
P
Schneider
Dietmar
D
Schwab
Stefan
S
Veltkamp
Roland
R
Walker
Michael
M
Streeter
Jackson
J
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