Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset
1 other identifier
interventional
660
4 countries
58
Brief Summary
The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2006
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 5, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 9, 2011
June 1, 2011
1.6 years
January 5, 2007
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disability scale (mRS)score at 90 days; safety of the treatment procedure
at baseline, day 5, 30, 60 and 90 post treatment
Secondary Outcomes (1)
Functional neurological scale(NIHSS)over time
at baseline, Day 5, 30, 60 and 90
Study Arms (2)
Transcranial Laser Therapy
EXPERIMENTALSham control procedure
SHAM COMPARATORInterventions
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Eligibility Criteria
You may qualify if:
- Diagnosis of Acute Ischemic Stroke within 24 hours
- NIHSS ≥7 - ≤22
You may not qualify if:
- \>24hours from symptom onset to time of treatment
- Evidence of intracranial, subdural, or subarachnoid hemorrhage
- Clinical presentation of intracranial hemorrhage
- Pre stroke ≥3 mRS
- The presence of a brainstem or cerebellar stroke
- Transient Ischemic Attack (TIA)
- Seizure at stroke onset
- Blood glucose \>400 or \<60
- Sustained systolic BP \>220mmHG \< 80mmHG or diastolic \>140mmHG \<50mmHG
- Septic embolus
- CNS tumor (except asymptomatic meningioma)
- Dermatologic condition of the scalp (e.g. Psoriasis)
- Thrombolytic therapy
- Head implant (e.g. Clipped aneurysm, Hakim valve)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PhotoThera, Inclead
Study Sites (58)
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
Alta Bates Summit Medical Center
Berkeley, California, 94705, United States
Scripps Encinitas Hospital
Encinitas, California, 92024, United States
Grossmont Hospital
La Mesa, California, 91942, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Tri City Medical Center
Oceanside, California, 92056, United States
Stanford Hospital and Clinics
Palo Alto, California, 94305, United States
Sharp Healthcare
San Diego, California, 92123, United States
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
The Stroke Center at Hartford Hospital
Hartford, Connecticut, 06102, United States
North Broward Medical Center
Deerfield Beach, Florida, 33064, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Health First Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
Naples Community Hospital
Naples, Florida, 34101, United States
Munroe Regional Medical Center
Ocala, Florida, 34474, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Dekalb Neurology Associates LLC
Decatur, Georgia, 30033, United States
The Queen's Medical Center
Honolulu, Hawaii, 92822, United States
Intensive Care Unit, Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Parkview Hospital
Fort Wayne, Indiana, 46805, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
North Memorial Medical Center
Robbinsdale, Minnesota, 55422, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Benefis Healthcare East Campus
Great Falls, Montana, 59405, United States
Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, 08060, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801, United States
UNC Health Care
Chapel Hill, North Carolina, 27514, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
The University Hospital
Cincinnati, Ohio, 45219, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Providence Portland Hospital
Portland, Oregon, 97213, United States
Oregon Health & Science University - Oregon Stroke Center
Portland, Oregon, 97239, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19140, United States
Roper Hospital
Charleston, South Carolina, 29401, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
The Methodist Hospital
Houston, Texas, 77030, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Sentara Virginia Beach General Hospital
Virginia Beach, Virginia, 23454, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Charleston Area Medical Center (CAMC) General Hospital
Charleston, West Virginia, 25301, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53795, United States
Neurologische Klinik des Universitatsklinikum Erlangen
Erlangen, Germany
Neurologische Klinik des Universitatsklinikum Heidelberg
Heidelberg, Germany
Klinik und Poliklinik fur Neurologic Leipzig
Leipzig, Germany
Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
Münster, Germany
Hospital Nacional "Dos de Mayo"
Lima, Peru
Sahlgrenska University Hospital
Gothenburg, Sweden
Sjukhuset i Lidkoping
Lidköping, Sweden
Related Publications (1)
Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.
PMID: 19233936RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Justin Zivin, MD, PhD
University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 5, 2007
First Posted
January 9, 2007
Study Start
December 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 9, 2011
Record last verified: 2011-06