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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT01120301

Run by

PhotoThera, Inc

People needed

1000

Starts

2010-09-01

Last updated by the study team

2013-11-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of acute ischemic stroke
• Subject is not a candidate for treatment with neurothrombectomy
• Initiation of the TLT procedure begins between 4.5 and 24 hours
• Baseline NIHSS score range: 7-17
• Full functional independence just prior to the present stroke episode
• Negative pregnancy test in females of childbearing potential
• Subject Informed Consent obtained prior to enrollment into this study

You may not qualify if…

• Evidence of an intracranial, subdural, or subarachnoid hemorrhage
• Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
• Seizure at stroke onset or within the 7 days prior to stroke onset
• Sustained blood glucose >300 or <60 mg/dl
• Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg)
• Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg)
• A presumed and/or confirmed septic embolus
• 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.
• Head implant of any kind
• Significant skin condition of the scalp (eg. psoriasis)
• Use of any intravenous or intra-arterial thrombolytic medication
• Use of any diagnostic or therapeutic interventional neurovascular procedure
• Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.

Where it is running

• 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
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Minneapolis Clinic of Neurology — Robbinsdale, Minnesota, United States
• Saint Lukes Hospital — Kansas City, Missouri, United States
• University of Washington St. Louis — St Louis, Missouri, United States
• Mission Hospital/Mission Neurology Services — Asheville, North Carolina, United States
• University of North Carolina Healthcare — Chapel Hill, North Carolina, United States
• Guilford Neuro/The Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States
• INOVA Hospital — Falls Church, Virginia, United States
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States
• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
• Winchester Medical Center — Winchester, Virginia, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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