The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,000
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Disability assessed using the dichotomous modified Rankin Scale (mRS)
Time frame: Day 90
Adverse event differences between transcranial laser therapy and sham
Time frame: Day 90
Distribution of scores across the ordinal mRS
Time frame: Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Time frame: Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama Birmingham
Birmingham, Alabama, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
Scripps Encinitas Hospital
Encinitas, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford Stroke Center
Palo Alto, California, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Gwinnett Medical Center
Duluth, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Parkview Hospital
Fort Wayne, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
...and 50 more locations