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 now accepting new patients for this trial. Please contact Stephanie Kemp at 6507234481 for more information.

Investigator(s):

Intervention(s):

  • device : NeuroThera® Laser System

Phase: Phase 3

Eligibility

Ages Eligible For Study:

40 Years - 80 Years

Inclusion Criteria

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

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Contact information

Primary Contact:

Stephanie Kemp 6507234481

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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