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 Hours of Stroke Onset
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Chitra Venkatasubramanian, MBBS, MD, MSc.
- Anna Finley Caulfield, MD
- Maarten Lansberg, MD, PhD
- Marion S. Buckwalter, MD, PhD
- device : NeuroThera® Laser System
Phase: Phase 3
Ages Eligible For Study:
1. Clinical diagnosis of acute ischemic stroke 2. Subject is not a candidate for treatment with neurothrombectomy 3. Initiation of the TLT procedure begins between 4.5 and 24 hours 4. Baseline NIHSS score range: 7-17 5. Full functional independence just prior to the present stroke episode 6. Negative pregnancy test in females of childbearing potential 7. Subject Informed Consent obtained prior to enrollment into this study