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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoThera, Inc
ClinicalTrials.gov Identifier:
NCT01120301
First received: May 5, 2010
Last updated: November 14, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Device: NeuroThera® Laser System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by PhotoThera, Inc:

Primary Outcome Measures:
  • Disability assessed using the dichotomous modified Rankin Scale (mRS) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Adverse event differences between transcranial laser therapy and sham [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: September 2010
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Laser Therapy Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Sham Comparator: Sham control procedure Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120301

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
Scripps Encinitas Hospital
Encinitas, California, United States, 92024
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Stanford Stroke Center
Palo Alto, California, United States, 94304
United States, Florida
Munroe Regional Medical Center
Ocala, Florida, United States, 34474
United States, Georgia
Gwinnett Medical Center
Duluth, Georgia, United States, 30096
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
United States, Indiana
Parkview Hospital
Fort Wayne, Indiana, United States, 46805
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Minneapolis Clinic of Neurology
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Saint Lukes Hospital
Kansas City, Missouri, United States, 64111
University of Washington St. Louis
St. Louis, Missouri, United States, 63110
United States, North Carolina
Mission Hospital/Mission Neurology Services
Asheville, North Carolina, United States, 28801
University of North Carolina Healthcare
Chapel Hill, North Carolina, United States, 27514
Guilford Neuro/The Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Tennessee
Erlanger Health System
Chattanooga, Tennessee, United States, 37403
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
INOVA Hospital
Falls Church, Virginia, United States, 22042
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Winchester Medical Center
Winchester, Virginia, United States, 22601
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Austria
AKH Linz
Linz, Austria, A-4021
Canada, Alberta
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
University of Alberta Hospital - Walter C Mackenzie Health Science Center
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Finland
Helsinki University Central Hospital
Helsinki, Finland, FI 00029
France
CHRU Lille-Hôpital Salengro
Lille, France, F-59037
Germany
Neurologische Universitätsklinik Aachen
Aachen, Germany, D-52074
Neurologische Klinik Bad Neustadt
Bad Neustadt, Germany, D-97616
Charité Campus Berlin Mitte (CCM)
Berlin, Germany, D-10117
Evangelisches Krankenhaus Bielefeld
Bielefeld, Germany, D-33617
Heinrich-Heine-University of Düsseldorf
Düsseldorf, Germany, D-40225
Neurologische Universitätsklinik Erlangen
Erlangen, Germany, D-91054
Universitätsklinikum Essen
Essen, Germany, D-45122
Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, D-60528
Klinikum Frankfurt-Hochst
Frankfurt-Main, Germany, D-65929
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, D-20246
Universitätsklinikum Heidelberg
Heidelberg, Germany, D-69120
Klinik und Poliklinik für Neurologie Leipzig
Leipzig, Germany, D-04103
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, Germany, D-67063
Johannes Wesling Klinikum Minden
Minden, Germany, D-32429
Technische Universität München
München, Germany, D-81675
Universitätsklinikum Münster
Münster, Germany, D-48149
Kreisklinikum Siegen GmbH
Siegen, Germany, D-57076
HSK, Dr. Horst Schmidt Klinik GmbH
Wiesbaden, Germany, D-65199
Peru
Hospital Nacional Dos de Mayo
Lima, Peru
Spain
Complejo Hospitalario Universitario Albacete
Albacete, Spain, ES-02006
University Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitari Dr Josep Trueta
Girona, Spain, ES-17007
Sweden
Sahlgrenska University Hospital
Goteborg, Sweden, SE-405 30
Sjukhuset i Lidköping
Lidköping, Sweden, SE-531 85
Kärnsjukhuset Skövde
Skövde, Sweden, SE-541 85
Switzerland
Universitätsspital Basel
Basel, Switzerland, CH-4031
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
University Hospital Zürich
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
PhotoThera, Inc
Investigators
Study Chair: Werner Hacke, MD PhD Heidelberg University
Study Chair: Justin Zivin, MD PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: PhotoThera, Inc
ClinicalTrials.gov Identifier: NCT01120301     History of Changes
Other Study ID Numbers: NTS-INT08-009
Study First Received: May 5, 2010
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
Finland: National Supervisory Authority for Welfare and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Peru: Instituto Nacional de Salud
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic

Keywords provided by PhotoThera, Inc:
stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014