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

Not Recruiting

Trial ID: NCT01120301


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

Stanford Investigator(s)

Anna Finley Caulfield, MD
Anna Finley Caulfield, MD

Clinical Professor, Neurology & Neurological Sciences

Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS
Chitra Venkatasubramanian, MBBS, MD, MSc, FNCS

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery

Maarten Lansberg, MD, PhD
Maarten Lansberg, MD, PhD

Professor of Neurology (Adult Neurology) and, by courtesy, of Neurosurgery


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

Exclusion Criteria:

   1. Evidence of an intracranial, subdural, or subarachnoid hemorrhage

   2. Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small
   deep infarctions, or massive hemispheric strokes

   3. Seizure at stroke onset or within the 7 days prior to stroke onset

   4. Sustained blood glucose >300 or <60 mg/dl

   5. 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 embolus

   8. 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

   9. Head implant of any kind

10. Significant skin condition of the scalp (eg. psoriasis)

11. Use of any intravenous or intra-arterial thrombolytic medication

12. Use of any diagnostic or therapeutic interventional neurovascular procedure

13. Female who is pregnant or lactating or who is of childbearing potential and not using
   a medically acceptable method of birth control.


device: NeuroThera® Laser System

Not Recruiting

Contact Information

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