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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:September 2010
Contact:Steven P Richieri
Email:srichieri@photothera.com
Phone:760-692-4924

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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.


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
assessment.

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.
We found this trial at
25
sites
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Ocala, Florida 34471
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3181 S.W. Sam Jackson Park Rd.
Portland, Oregon 97201
503 494-8311
Oregon Health Sciences University In 1887, the inaugural class of the University of Oregon Medical...
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Asheville, North Carolina 28801
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Chapel Hill, North Carolina 27514
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Chattanooga, Tennessee 37403
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Encinitas, California 92024
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Falls Church, Virginia 22042
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Fort Smith, Arkansas 72901
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Fort Wayne, Indiana 46805
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Greensboro, North Carolina 27401
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Kansas City, Missouri 64111
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Lawrenceville, Georgia 30045
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Newport Beach, California 92658
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Palo Alto, California 94304
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Roanoke, Virginia 24033
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Robbinsdale, Minnesota 55426
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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St. Louis, Missouri 63110
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Winchester, Virginia 22604
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55 Lake Avenue North
Worcester, Massachusetts 01655
508-334-1000
Umass Memorial Medical Center UMass Memorial Medical Center is the region's trusted academic medical center,...
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