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

November 14, 2013 updated by: PhotoThera, Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disability assessed using the dichotomous modified Rankin Scale (mRS)
Time Frame: Day 90
Day 90
Adverse event differences between transcranial laser therapy and sham
Time Frame: Day 90
Day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Distribution of scores across the ordinal mRS
Time Frame: Day 90
Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Time Frame: Day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhotoThera, Inc

Investigators

  • Study Chair: Werner Hacke, MD PhD, Heidelberg University
  • Study Chair: Justin Zivin, MD PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2013

Last Update Submitted That Met QC Criteria

November 14, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTS-INT08-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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