Next Step: Proving Efficacy
In addition to the inclusion of patients with severe baseline stroke scores, one potential weakness of the study was the insufficient human experience with this therapy. Additional trials will be needed to find the treatment groups who can be most helped by the therapy. Also, because transcranial laser therapy lacks many unpleasant side effects, a low barrier to treatment is expected.
Dr. Zivin’s group noted the possibility that transcranial laser therapy might not have any effect on stroke recovery. “However, substantial preclinical studies, the NEST-1 study, and the trends in the current trial argue against this unfavorable interpretation,” they said.
“The effect size of transcranial laser treatment for the treatment of ischemic stroke in humans within 24 hours of stroke onset was inadequate to meet conventional levels of statistical significance for efficacy, even when the corrections were made for the baseline imbalances in stroke severity and time to treatment, but showed a consistent signal toward better outcomes associated with transcranial laser treatment,” the researchers added.
“Perhaps the most important result of this trial, aside from the initial primary end point, is that this is a forest plot showing whether the laser therapy was better or worse than placebo,” concluded Dr. Zivin. “As a result of all this, we are quite encouraged, and a multinational phase three study is planned, which will be called NEST-3.”
—Laura Sassano