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

Phase 3

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: NeuroThera® Laser System

• Registration Number: NCT01120301
• Lead Sponsor: PhotoThera, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-10
• Study Start: 2010-09
• Primary Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & 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
Adverse event differences between transcranial laser therapy and sham	Day 90
Disability assessed using the dichotomous modified Rankin Scale (mRS)	Day 90

Secondary Outcome Measures

Name	Time	Method
Distribution of scores across the ordinal mRS	Day 90
Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)	Day 90

Trial Locations

Locations (59)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Hoag Memorial Hospital Presbyterian; 🇺🇸 Newport Beach, California, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

AKH Linz; 🇦🇹 Linz, Austria

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Winchester Medical Center; 🇺🇸 Winchester, Virginia, United States

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Gwinnett Medical Center; 🇺🇸 Lawrenceville, Georgia, United States

Minneapolis Clinic of Neurology; 🇺🇸 Robbinsdale, Minnesota, United States

University of Washington St. Louis; 🇺🇸 St. Louis, Missouri, United States

Neurologische Klinik Bad Neustadt; 🇩🇪 Bad Neustadt, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Heinrich-Heine-University of Düsseldorf; 🇩🇪 Düsseldorf, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Sjukhuset i Lidköping; 🇸🇪 Lidköping, Sweden

Kärnsjukhuset Skövde; 🇸🇪 Skövde, Sweden

Sparks Regional Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Scripps Encinitas Hospital; 🇺🇸 Encinitas, California, United States

University Hospital Vall D'Hebron; 🇪🇸 Barcelona, Spain

Neurologische Universitätsklinik Erlangen; 🇩🇪 Erlangen, Germany

Complejo Hospitalario Universitario Albacete; 🇪🇸 Albacete, Spain

Klinikum der Stadt Ludwigshafen am Rhein; 🇩🇪 Ludwigshafen, Germany

HSK, Dr. Horst Schmidt Klinik GmbH; 🇩🇪 Wiesbaden, Germany

Hospital Universitari Dr Josep Trueta; 🇪🇸 Girona, Spain

Munroe Regional Medical Center; 🇺🇸 Ocala, Florida, United States

Charité Campus Berlin Mitte (CCM); 🇩🇪 Berlin, Germany

Neurologische Universitätsklinik Aachen; 🇩🇪 Aachen, Germany

Hospital Nacional Dos de Mayo; 🇵🇪 Lima, Peru

Parkview Hospital; 🇺🇸 Fort Wayne, Indiana, United States

Technische Universität München; 🇩🇪 München, Germany

Guilford Neuro/The Moses H. Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States

Carilion Roanoke Memorial Hospital; 🇺🇸 Roanoke, Virginia, United States

Klinikum Frankfurt-Hochst; 🇩🇪 Frankfurt-Main, Germany

CHRU Lille-Hôpital Salengro; 🇫🇷 Lille, France

Evangelisches Krankenhaus Bielefeld; 🇩🇪 Bielefeld, Germany

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Stanford Stroke Center; 🇺🇸 Palo Alto, California, United States

Mission Hospital/Mission Neurology Services; 🇺🇸 Asheville, North Carolina, United States

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States

University of Alberta Hospital - Walter C Mackenzie Health Science Center; 🇨🇦 Edmonton, Alberta, Canada

Trillium Health Centre; 🇨🇦 Mississauga, Ontario, Canada

Johann Wolfgang Goethe-University; 🇩🇪 Frankfurt am Main, Germany

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Klinik und Poliklinik für Neurologie Leipzig; 🇩🇪 Leipzig, Germany

Sahlgrenska University Hospital; 🇸🇪 Goteborg, Sweden

Kreisklinikum Siegen GmbH; 🇩🇪 Siegen, Germany

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Saint Lukes Hospital; 🇺🇸 Kansas City, Missouri, United States

University of North Carolina Healthcare; 🇺🇸 Chapel Hill, North Carolina, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

INOVA Hospital; 🇺🇸 Falls Church, Virginia, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States