Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
NCT ID: NCT01120301
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transcranial Laser Therapy
NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Sham control procedure
NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Interventions
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NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
No
Sponsors
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PhotoThera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Werner Hacke, MD PhD
Role: STUDY_CHAIR
Heidelberg University
Justin Zivin, MD PhD
Role: STUDY_CHAIR
University of California, San Diego
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
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
Harborview Medical Center
Seattle, Washington, United States
AKH Linz
Linz, , Austria
University of Alberta Hospital - Walter C Mackenzie Health Science Center
Edmonton, Alberta, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Helsinki University Central Hospital
Helsinki, , Finland
CHRU Lille-Hôpital Salengro
Lille, , France
Neurologische Universitätsklinik Aachen
Aachen, , Germany
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, , Germany
Charité Campus Berlin Mitte (CCM)
Berlin, , Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, , Germany
Heinrich-Heine-University of Düsseldorf
Düsseldorf, , Germany
Neurologische Universitätsklinik Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Johann Wolfgang Goethe-University
Frankfurt am Main, , Germany
Klinikum Frankfurt-Hochst
Frankfurt am Main, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Klinik und Poliklinik für Neurologie Leipzig
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Technische Universität München
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Kreisklinikum Siegen GmbH
Siegen, , Germany
HSK, Dr. Horst Schmidt Klinik GmbH
Wiesbaden, , Germany
Hospital Nacional Dos de Mayo
Lima, , Peru
Complejo Hospitalario Universitario Albacete
Albacete, , Spain
University Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Universitari Dr Josep Trueta
Girona, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Sjukhuset i Lidköping
Lidköping, , Sweden
Kärnsjukhuset Skövde
Skövde, , Sweden
Universitätsspital Basel
Basel, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Countries
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References
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Hacke W, Schellinger PD, Albers GW, Bornstein NM, Dahlof BL, Fulton R, Kasner SE, Shuaib A, Richieri SP, Dilly SG, Zivin J, Lees KR; NEST 3 Committees and Investigators. Transcranial laser therapy in acute stroke treatment: results of neurothera effectiveness and safety trial 3, a phase III clinical end point device trial. Stroke. 2014 Nov;45(11):3187-93. doi: 10.1161/STROKEAHA.114.005795. Epub 2014 Oct 7.
Other Identifiers
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NTS-INT08-009
Identifier Type: -
Identifier Source: org_study_id