NeuroThera® Efficacy and Safety Trial – 3 (NEST-3): A Double-Blind, Randomized, Sham-Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy with the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke within 24 h of Stroke Onset

• Published in: International journal of stroke Vol. 9; no. 7; pp. 950 - 955
• Main Authors: Zivin, J. A., Sehra, R., Shoshoo, A., Albers, G. W., Bornstein, N. M., Dahlof, B., Kasner, S. E., Howard, G., Shuaib, A., Streeter, J., Richieri, S. P., Hacke, W.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-10-2014
• Subjects: acute ischemic stroke; Adult; Aged; Aged, 80 and over; Brain Ischemia - therapy; clinical trial; Double-Blind Method; Follow-Up Studies; Humans; Laser Therapy - adverse effects; Laser Therapy - instrumentation; Laser Therapy - methods; Middle Aged; Patient Selection; Stroke - therapy; stroke outcomes; Time-to-Treatment; transcranial laser therapy; Treatment Outcome; clinical trial; stroke outcomes; acute ischemic stroke; transcranial laser therapy
• ISSN: 1747-4930; 1747-4949
• DOI: 10.1111/j.1747-4949.2012.00896.x

Rationale
Transcranial laser therapy is undergoing clinical trials in patients with acute ischemic stroke. The NeuroThera® Efficacy and Safety Trial-1 was strongly positive for 90-day functional benefit with transcranial laser therapy, and post hoc analyses of the subsequent NeuroThera® Efficacy and Safety Trial-2 trial suggested a meaningful beneficial effect in patients with moderate to moderately severe ischemic stroke within 24 h of onset. These served as the basis for the NeuroThera® Efficacy and Safety Trial-3 randomized controlled trial.
Aim
The purpose of this pivotal study was to demonstrate safety and efficacy of transcranial laser therapy with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke.
Design
NeuroThera® Efficacy and Safety Trial-3 is a double-blind, randomized, sham-controlled, parallel group, multicenter, pivotal study that will enroll 1000 subjects at up to 50 sites. All subjects will receive standard medical management based on the American Stroke Association and European Stroke Organization Guidelines. In addition to standard medical management, both groups will undergo the transcranial laser therapy procedure between 4·5 and 24 h of stroke onset. The study population will be randomized into two arms: the sham control group will receive a sham transcranial laser therapy procedure and the transcranial laser therapy group will receive an active transcranial laser therapy procedure. The randomization ratio will be 1:1 and will be stratified to ensure a balanced subject distribution between study arms.
Study Outcomes
The primary efficacy end point is disability at 90 days (or the last rating), as assessed on the modified Rankin Scale, dichotomized as a success (a score of 0–2) or a failure (a score of 3 to 6).