Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
NEST-3
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
1 other identifier
interventional
1,000
10 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
60 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
First Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedNovember 15, 2013
October 1, 2012
2 years
May 5, 2010
November 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disability assessed using the dichotomous modified Rankin Scale (mRS)
Day 90
Adverse event differences between transcranial laser therapy and sham
Day 90
Secondary Outcomes (2)
Distribution of scores across the ordinal mRS
Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Day 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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PhotoThera, Inclead
Study Sites (60)
University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
Scripps Encinitas Hospital
Encinitas, California, 92024, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Stanford Stroke Center
Palo Alto, California, 94304, United States
Munroe Regional Medical Center
Ocala, Florida, 34474, United States
Gwinnett Medical Center
Duluth, Georgia, 30096, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Parkview Hospital
Fort Wayne, Indiana, 46805, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Minneapolis Clinic of Neurology
Robbinsdale, Minnesota, 55422, United States
Saint Lukes Hospital
Kansas City, Missouri, 64111, United States
University of Washington St. Louis
St Louis, Missouri, 63110, United States
Mission Hospital/Mission Neurology Services
Asheville, North Carolina, 28801, United States
University of North Carolina Healthcare
Chapel Hill, North Carolina, 27514, United States
Guilford Neuro/The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Erlanger Health System
Chattanooga, Tennessee, 37403, United States
The Methodist Hospital
Houston, Texas, 77030, United States
INOVA Hospital
Falls Church, Virginia, 22042, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Winchester Medical Center
Winchester, Virginia, 22601, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
AKH Linz
Linz, A-4021, Austria
University of Alberta Hospital - Walter C Mackenzie Health Science Center
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8, Canada
Helsinki University Central Hospital
Helsinki, FI 00029, Finland
CHRU Lille-Hôpital Salengro
Lille, F-59037, France
Neurologische Universitätsklinik Aachen
Aachen, D-52074, Germany
Neurologische Klinik Bad Neustadt
Bad Neustadt an der Saale, D-97616, Germany
Charité Campus Berlin Mitte (CCM)
Berlin, D-10117, Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, D-33617, Germany
Heinrich-Heine-University of Düsseldorf
Düsseldorf, D-40225, Germany
Neurologische Universitätsklinik Erlangen
Erlangen, D-91054, Germany
Universitätsklinikum Essen
Essen, D-45122, Germany
Johann Wolfgang Goethe-University
Frankfurt am Main, D-60528, Germany
Klinikum Frankfurt-Hochst
Frankfurt am Main, D-65929, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, D-20246, Germany
Universitätsklinikum Heidelberg
Heidelberg, D-69120, Germany
Klinik und Poliklinik für Neurologie Leipzig
Leipzig, D-04103, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, D-67063, Germany
Johannes Wesling Klinikum Minden
Minden, D-32429, Germany
Technische Universität München
München, D-81675, Germany
Universitätsklinikum Münster
Münster, D-48149, Germany
Kreisklinikum Siegen GmbH
Siegen, D-57076, Germany
HSK, Dr. Horst Schmidt Klinik GmbH
Wiesbaden, D-65199, Germany
Hospital Nacional Dos de Mayo
Lima, Peru
Complejo Hospitalario Universitario Albacete
Albacete, ES-02006, Spain
University Hospital Vall D'Hebron
Barcelona, 08035, Spain
Hospital Universitari Dr Josep Trueta
Girona, ES-17007, Spain
Sahlgrenska University Hospital
Gothenburg, SE-405 30, Sweden
Sjukhuset i Lidköping
Lidköping, SE-531 85, Sweden
Kärnsjukhuset Skövde
Skövde, SE-541 85, Sweden
Universitätsspital Basel
Basel, CH-4031, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011, Switzerland
University Hospital Zürich
Zurich, CH-8091, Switzerland
Related Publications (1)
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.
PMID: 25293665DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Werner Hacke, MD PhD
Heidelberg University
- STUDY CHAIR
Justin Zivin, MD PhD
University of California, San Diego
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 10, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2012
Last Updated
November 15, 2013
Record last verified: 2012-10