Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)
- Conditions
- Ischemic Stroke
- Interventions
- Device: NeuroThera® Laser System
- Registration Number
- NCT00419705
- Lead Sponsor
- PhotoThera, Inc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
- 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
- >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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transcranial Laser Therapy NeuroThera® Laser System - Sham control procedure NeuroThera® Laser System -
- Primary Outcome Measures
Name Time Method Disability scale (mRS)score at 90 days; safety of the treatment procedure at baseline, day 5, 30, 60 and 90 post treatment
- Secondary Outcome Measures
Name Time Method Functional neurological scale(NIHSS)over time at baseline, Day 5, 30, 60 and 90
Trial Locations
- Locations (58)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
The Stroke Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Dekalb Medical Center
🇺🇸Decatur, Georgia, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Benefis Healthcare East Campus
🇺🇸Great Falls, Montana, United States
Hospital Nacional "Dos de Mayo"
🇵🇪Lima, Peru
Dekalb Neurology Associates LLC
🇺🇸Decatur, Georgia, United States
Mission Hospitals - Memorial Campus
🇺🇸Asheville, North Carolina, United States
Neurologische Klinik des Universitatsklinikum Erlangen
🇩🇪Erlangen, Germany
University Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Sahlgrenska University Hospital
🇸🇪Goteborg, Sweden
North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Charleston Area Medical Center (CAMC) General Hospital
🇺🇸Charleston, West Virginia, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison,, Wisconsin, United States
University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
The Moses H. Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Intensive Care Unit, Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Sjukhuset i Lidkoping
🇸🇪Lidkoping, Sweden
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
Hospital of University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Sentara Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
The University Hospital
🇺🇸Cincinnati, Ohio, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Providence Portland Hospital
🇺🇸Portland, Oregon, United States
Oregon Health & Science University - Oregon Stroke Center
🇺🇸Portland, Oregon, United States
Stanford Hospital and Clinics
🇺🇸Palo Alto, California, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Scripps Encinitas Hospital
🇺🇸Encinitas, California, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Tri City Medical Center
🇺🇸Oceanside, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Grossmont Hospital
🇺🇸La Mesa, California, United States
Holy Cross Hospital
🇺🇸Ft. Lauderdale, Florida, United States
North Broward Medical Center
🇺🇸Deerfield Beach, Florida, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States
Fawcett Memorial Hospital
🇺🇸Port Charlotte, Florida, United States
Klinik und Poliklinik fur Neurologic Leipzig
🇩🇪Leipzig, Germany
Winchester Medical Center
🇺🇸Winchester, Virginia, United States
Neurology Medical Group of Diablo Valley
🇺🇸Walnut Creek, California, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
Health First Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Neurologische Klinik und Poliklinik Westfalische Wilhelms Universitat
🇩🇪Munster, Germany
Virtua Memorial Hospital of Burlington County
🇺🇸Mount Holly, New Jersey, United States
Neurologische Klinik des Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Roper Hospital
🇺🇸Charleston, South Carolina, United States
UNC Health Care
🇺🇸Chapel Hill, North Carolina, United States
Sharp Healthcare
🇺🇸San Diego, California, United States