Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Clinical diagnosis of acute ischemic stroke2. Subject is not a candidate for treatment with neurothrombectomy3. Initiation of the TLT procedure begins between 4.5 and 24 hours4. Baseline NIHSS score range: 7-175. Full functional independence just prior to the present stroke episode6. Negative pregnancy test in females of childbearing potential7. Subject Informed Consent obtained prior to enrollment into this study
Exclusion Criteria:
  1. 1. Evidence of an intracranial, subdural, or subarachnoid hemorrhage2. Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes3. Seizure at stroke onset or within the 7 days prior to stroke onset4. Sustained blood glucose \>300 or \<60 mg/dl5. Sustained hypertension (SBP \>220 mmHg or DBP \>140 mmHg)6. Sustained hypotension (SBP \<80 mmHg or DBP \<50 mmHg)7. A presumed and/or confirmed septic embolus8. History of CNS vascular disease (e.g. aneurysm, AVM) or history of CNS disease or damage (e.g. neoplasm or dementia) which may influence the subject's outcome assessment.9. Head implant of any kind10. Significant skin condition of the scalp (eg. psoriasis)11. Use of any intravenous or intra-arterial thrombolytic medication12. Use of any diagnostic or therapeutic interventional neurovascular procedure13. Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.


Anna Finley Caulfield, MD
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Stroke and vascular neurologist, Neurocritical care specialist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD
Stroke and vascular neurologist, General neurologist
Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery

Contact us to find out if this trial is right for you.


Stephanie Kemp