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

NCT ID: NCT00419705

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-07-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Transcranial Laser Therapy

Group Type: EXPERIMENTAL

NeuroThera® Laser System

Intervention Type: DEVICE

Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Sham control procedure

Group Type: SHAM_COMPARATOR

NeuroThera® Laser System

Intervention Type: DEVICE

Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Interventions

NeuroThera® Laser System

Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PhotoThera, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

PhotoThera, Inc

Principal Investigators

Justin Zivin, MD, PhD

Role: STUDY_CHAIR

University of California San Diego, Department of Neurosciences; 9500 Gillman Drive; La Jolla, CA 92093

Locations

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Alta Bates Summit Medical Center

Berkeley, California, United States

Scripps Encinitas Hospital

Encinitas, California, United States

Grossmont Hospital

La Mesa, California, United States

UCLA Medical Center

Los Angeles, California, United States

Tri City Medical Center

Oceanside, California, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

Sharp Healthcare

San Diego, California, United States

Neurology Medical Group of Diablo Valley

Walnut Creek, California, United States

Swedish Medical Center

Englewood, Colorado, United States

The Stroke Center at Hartford Hospital

Hartford, Connecticut, United States

North Broward Medical Center

Deerfield Beach, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Health First Holmes Regional Medical Center

Melbourne, Florida, United States

Naples Community Hospital

Naples, Florida, United States

Munroe Regional Medical Center

Ocala, Florida, United States

Fawcett Memorial Hospital

Port Charlotte, Florida, United States

Dekalb Medical Center

Decatur, Georgia, United States

Dekalb Neurology Associates LLC

Decatur, Georgia, United States

The Queen's Medical Center

Honolulu, Hawaii, United States

Intensive Care Unit, Northwestern Memorial Hospital

Chicago, Illinois, United States

Loyola University Chicago

Maywood, Illinois, United States

Parkview Hospital

Fort Wayne, Indiana, United States

University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

North Memorial Medical Center

Robbinsdale, Minnesota, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

Benefis Healthcare East Campus

Great Falls, Montana, United States

Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

UNC Health Care

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

The Moses H. Cone Memorial Hospital

Greensboro, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

The University Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Providence Portland Hospital

Portland, Oregon, United States

Oregon Health & Science University - Oregon Stroke Center

Portland, Oregon, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, United States

Roper Hospital

Charleston, South Carolina, United States

Erlanger Health System

Chattanooga, Tennessee, United States

The Methodist Hospital

Houston, Texas, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Sentara Virginia Beach General Hospital

Virginia Beach, Virginia, United States

Winchester Medical Center

Winchester, Virginia, United States

Charleston Area Medical Center (CAMC) General Hospital

Charleston, West Virginia, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Neurologische Klinik des Universitatsklinikum Erlangen

Erlangen, , Germany

Neurologische Klinik des Universitatsklinikum Heidelberg

Heidelberg, , Germany

Klinik und Poliklinik fur Neurologic Leipzig

Leipzig, , Germany

Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat

Münster, , Germany

Hospital Nacional "Dos de Mayo"

Lima, , Peru

Sahlgrenska University Hospital

Gothenburg, , Sweden

Sjukhuset i Lidkoping

Lidköping, , Sweden

Countries

United States; Germany; Peru; Sweden

References

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.

Reference Type: RESULT

PMID: 19233936 (View on PubMed)

Other Identifiers

NTS-INT06-007

Identifier Type: -

Identifier Source: org_study_id