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Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

Primary Purpose

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 Ischemic Stroke focused on measuring acute stroke, infrared laser therapy, clinical trial, safety, effectiveness

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of Acute Ischemic Stroke within 24 hours
  2. Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
  3. NIHSS ≥7 - ≤22

Exclusion Criteria:

  1. >24hours from symptom onset to time of treatment
  2. Evidence of intracranial, subdural, or subarachnoid hemorrhage
  3. Clinical presentation of intracranial hemorrhage
  4. Pre stroke ≥3 mRS
  5. The presence of a brainstem or cerebellar stroke
  6. Transient Ischemic Attack (TIA)
  7. Seizure at stroke onset
  8. Blood glucose >400 or <60
  9. Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
  10. Septic embolus
  11. CNS tumor (except asymptomatic meningioma)
  12. Dermatologic condition of the scalp (e.g. Psoriasis)
  13. Thrombolytic therapy
  14. Head implant (e.g. Clipped aneurysm, Hakim valve)

Sites / Locations

  • Sparks Regional Medical Center
  • Alta Bates Summit Medical Center
  • Scripps Encinitas Hospital
  • Grossmont Hospital
  • UCLA Medical Center
  • Tri City Medical Center
  • Stanford Hospital and Clinics
  • Sharp Healthcare
  • Neurology Medical Group of Diablo Valley
  • Swedish Medical Center
  • The Stroke Center at Hartford Hospital
  • North Broward Medical Center
  • Holy Cross Hospital
  • Health First Holmes Regional Medical Center
  • Naples Community Hospital
  • Munroe Regional Medical Center
  • Fawcett Memorial Hospital
  • Dekalb Medical Center
  • Dekalb Neurology Associates LLC
  • The Queen's Medical Center
  • Intensive Care Unit, Northwestern Memorial Hospital
  • Loyola University Chicago
  • Parkview Hospital
  • University of Kentucky Chandler Medical Center
  • Beth Israel Deaconess Medical Center
  • University Massachusetts Memorial Medical Center
  • North Memorial Medical Center
  • St. Luke's Hospital
  • Saint Louis University
  • Benefis Healthcare East Campus
  • Virtua Memorial Hospital of Burlington County
  • The Valley Hospital
  • Mission Hospitals - Memorial Campus
  • UNC Health Care
  • Duke University Medical Center
  • The Moses H. Cone Memorial Hospital
  • Forsyth Medical Center
  • The University Hospital
  • The Cleveland Clinic Foundation
  • Providence Portland Hospital
  • Oregon Health & Science University - Oregon Stroke Center
  • Thomas Jefferson University Hospital
  • Hospital of University of Pennsylvania
  • Roper Hospital
  • Erlanger Health System
  • The Methodist Hospital
  • Virginia Commonwealth University Medical Center
  • Sentara Virginia Beach General Hospital
  • Winchester Medical Center
  • Charleston Area Medical Center (CAMC) General Hospital
  • University of Wisconsin Hospital and Clinics
  • Neurologische Klinik des Universitatsklinikum Erlangen
  • Neurologische Klinik des Universitatsklinikum Heidelberg
  • Klinik und Poliklinik fur Neurologic Leipzig
  • Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
  • Hospital Nacional "Dos de Mayo"
  • Sahlgrenska University Hospital
  • Sjukhuset i Lidkoping

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 scale (mRS)score at 90 days; safety of the treatment procedure

Secondary Outcome Measures

Functional neurological scale(NIHSS)over time

Full Information

First Posted
January 5, 2007
Last Updated
June 7, 2011
Sponsor
PhotoThera, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00419705
Brief Title
Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
Official Title
NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

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 effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
Detailed Description
This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute stroke, infrared laser therapy, clinical trial, safety, effectiveness

7. Study Design

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

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 scale (mRS)score at 90 days; safety of the treatment procedure
Time Frame
at baseline, day 5, 30, 60 and 90 post treatment
Secondary Outcome Measure Information:
Title
Functional neurological scale(NIHSS)over time
Time Frame
at baseline, Day 5, 30, 60 and 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Acute Ischemic Stroke within 24 hours Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences NIHSS ≥7 - ≤22 Exclusion Criteria: >24hours from symptom onset to time of treatment Evidence of intracranial, subdural, or subarachnoid hemorrhage Clinical presentation of intracranial hemorrhage Pre stroke ≥3 mRS The presence of a brainstem or cerebellar stroke Transient Ischemic Attack (TIA) Seizure at stroke onset Blood glucose >400 or <60 Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG Septic embolus CNS tumor (except asymptomatic meningioma) Dermatologic condition of the scalp (e.g. Psoriasis) Thrombolytic therapy Head implant (e.g. Clipped aneurysm, Hakim valve)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Zivin, MD, PhD
Organizational Affiliation
University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093
Official's Role
Study Chair
Facility Information:
Facility Name
Sparks Regional Medical Center
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Facility Name
Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Scripps Encinitas Hospital
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Tri City Medical Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Neurology Medical Group of Diablo Valley
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
The Stroke Center at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
North Broward Medical Center
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Holy Cross Hospital
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Health First Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Naples Community Hospital
City
Naples
State/Province
Florida
ZIP/Postal Code
34101
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Fawcett Memorial Hospital
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Dekalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Dekalb Neurology Associates LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
92822
Country
United States
Facility Name
Intensive Care Unit, Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Benefis Healthcare East Campus
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Virtua Memorial Hospital of Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Mission Hospitals - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
UNC Health Care
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence Portland Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health & Science University - Oregon Stroke Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
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
Virginia Commonwealth University Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Sentara Virginia Beach General Hospital
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Charleston Area Medical Center (CAMC) General Hospital
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison,
State/Province
Wisconsin
ZIP/Postal Code
53795
Country
United States
Facility Name
Neurologische Klinik des Universitatsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Neurologische Klinik des Universitatsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinik und Poliklinik fur Neurologic Leipzig
City
Leipzig
Country
Germany
Facility Name
Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
City
Munster
Country
Germany
Facility Name
Hospital Nacional "Dos de Mayo"
City
Lima
Country
Peru
Facility Name
Sahlgrenska University Hospital
City
Goteborg
Country
Sweden
Facility Name
Sjukhuset i Lidkoping
City
Lidkoping
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19233936
Citation
Zivin JA, Albers GW, Bornstein N, Chippendale T, Dahlof B, Devlin T, Fisher M, Hacke W, Holt W, Ilic S, Kasner S, Lew R, Nash M, Perez J, Rymer M, Schellinger P, Schneider D, Schwab S, Veltkamp R, Walker M, Streeter J; NeuroThera Effectiveness and Safety Trial-2 Investigators. Effectiveness and safety of transcranial laser therapy for acute ischemic stroke. Stroke. 2009 Apr;40(4):1359-64. doi: 10.1161/STROKEAHA.109.547547. Epub 2009 Feb 20.
Results Reference
result

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Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

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