search
Back to results

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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NeuroThera® Laser System
Sponsored by
PhotoThera, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama Birmingham
  • Sparks Regional Medical Center
  • Scripps Encinitas Hospital
  • Hoag Memorial Hospital Presbyterian
  • Stanford Stroke Center
  • Munroe Regional Medical Center
  • Gwinnett Medical Center
  • Gwinnett Medical Center
  • Parkview Hospital
  • Massachusetts General Hospital
  • UMass Memorial Medical Center
  • Minneapolis Clinic of Neurology
  • Saint Lukes Hospital
  • University of Washington St. Louis
  • Mission Hospital/Mission Neurology Services
  • University of North Carolina Healthcare
  • Guilford Neuro/The Moses H. Cone Memorial Hospital
  • Cleveland Clinic
  • Oregon Health Sciences University
  • Erlanger Health System
  • The Methodist Hospital
  • INOVA Hospital
  • Sentara Norfolk General Hospital
  • Carilion Roanoke Memorial Hospital
  • Winchester Medical Center
  • Harborview Medical Center
  • AKH Linz
  • University of Alberta Hospital - Walter C Mackenzie Health Science Center
  • Grey Nuns Community Hospital
  • Trillium Health Centre
  • Helsinki University Central Hospital
  • CHRU Lille-Hôpital Salengro
  • Neurologische Universitätsklinik Aachen
  • Neurologische Klinik Bad Neustadt
  • Charité Campus Berlin Mitte (CCM)
  • Evangelisches Krankenhaus Bielefeld
  • Heinrich-Heine-University of Düsseldorf
  • Neurologische Universitätsklinik Erlangen
  • Universitätsklinikum Essen
  • Johann Wolfgang Goethe-University
  • Klinikum Frankfurt-Hochst
  • Universitätsklinikum Hamburg-Eppendorf
  • Universitätsklinikum Heidelberg
  • Klinik und Poliklinik für Neurologie Leipzig
  • Klinikum der Stadt Ludwigshafen am Rhein
  • Johannes Wesling Klinikum Minden
  • Technische Universität München
  • Universitätsklinikum Münster
  • Kreisklinikum Siegen GmbH
  • HSK, Dr. Horst Schmidt Klinik GmbH
  • Hospital Nacional Dos de Mayo
  • Complejo Hospitalario Universitario Albacete
  • University Hospital Vall D'Hebron
  • Hospital Universitari Dr Josep Trueta
  • Sahlgrenska University Hospital
  • Sjukhuset i Lidköping
  • Kärnsjukhuset Skövde
  • Universitätsspital Basel
  • Centre Hospitalier Universitaire Vaudois
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Laser Therapy

Sham control procedure

Arm Description

Outcomes

Primary Outcome Measures

Disability assessed using the dichotomous modified Rankin Scale (mRS)
Adverse event differences between transcranial laser therapy and sham

Secondary Outcome Measures

Distribution of scores across the ordinal mRS
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)

Full Information

First Posted
May 5, 2010
Last Updated
November 14, 2013
Sponsor
PhotoThera, Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT01120301
Brief Title
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
Acronym
NEST-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhotoThera, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Laser Therapy
Arm Type
Experimental
Arm Title
Sham control procedure
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
NeuroThera® Laser System
Intervention Description
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Primary Outcome Measure Information:
Title
Disability assessed using the dichotomous modified Rankin Scale (mRS)
Time Frame
Day 90
Title
Adverse event differences between transcranial laser therapy and sham
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Distribution of scores across the ordinal mRS
Time Frame
Day 90
Title
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Hacke, MD PhD
Organizational Affiliation
Heidelberg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Justin Zivin, MD PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Scripps Encinitas Hospital
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Stanford Stroke Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Gwinnett Medical Center
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Saint Lukes Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Washington St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mission Hospital/Mission Neurology Services
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina Healthcare
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Guilford Neuro/The Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Erlanger Health System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
INOVA Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
AKH Linz
City
Linz
ZIP/Postal Code
A-4021
Country
Austria
Facility Name
University of Alberta Hospital - Walter C Mackenzie Health Science Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FI 00029
Country
Finland
Facility Name
CHRU Lille-Hôpital Salengro
City
Lille
ZIP/Postal Code
F-59037
Country
France
Facility Name
Neurologische Universitätsklinik Aachen
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Neurologische Klinik Bad Neustadt
City
Bad Neustadt
ZIP/Postal Code
D-97616
Country
Germany
Facility Name
Charité Campus Berlin Mitte (CCM)
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
ZIP/Postal Code
D-33617
Country
Germany
Facility Name
Heinrich-Heine-University of Düsseldorf
City
Düsseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Neurologische Universitätsklinik Erlangen
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Johann Wolfgang Goethe-University
City
Frankfurt am Main
ZIP/Postal Code
D-60528
Country
Germany
Facility Name
Klinikum Frankfurt-Hochst
City
Frankfurt-Main
ZIP/Postal Code
D-65929
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Klinik und Poliklinik für Neurologie Leipzig
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen
ZIP/Postal Code
D-67063
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
ZIP/Postal Code
D-32429
Country
Germany
Facility Name
Technische Universität München
City
München
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Kreisklinikum Siegen GmbH
City
Siegen
ZIP/Postal Code
D-57076
Country
Germany
Facility Name
HSK, Dr. Horst Schmidt Klinik GmbH
City
Wiesbaden
ZIP/Postal Code
D-65199
Country
Germany
Facility Name
Hospital Nacional Dos de Mayo
City
Lima
Country
Peru
Facility Name
Complejo Hospitalario Universitario Albacete
City
Albacete
ZIP/Postal Code
ES-02006
Country
Spain
Facility Name
University Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari Dr Josep Trueta
City
Girona
ZIP/Postal Code
ES-17007
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Goteborg
ZIP/Postal Code
SE-405 30
Country
Sweden
Facility Name
Sjukhuset i Lidköping
City
Lidköping
ZIP/Postal Code
SE-531 85
Country
Sweden
Facility Name
Kärnsjukhuset Skövde
City
Skövde
ZIP/Postal Code
SE-541 85
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
University Hospital Zürich
City
Zürich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25293665
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs