Clinical trial NCT01120301: Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: stroke
Lead sponsor: PhotoThera, Inc
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disability assessed using the dichotomous modified Rankin Scale (mRS)
timeFrame: Day 90
measure: Adverse event differences between transcranial laser therapy and sham
timeFrame: Day 90
Secondary outcomes:
measure: Distribution of scores across the ordinal mRS
timeFrame: Day 90
measure: Binary outcome measure of the National Institute of Health Stroke Scale (bNIH)
timeFrame: Day 90
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Encinitas
country: United States
facility: Scripps Encinitas Hospital
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palo Alto
country: United States
facility: Stanford Stroke Center
state: California
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Duluth
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Robbinsdale
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Kansas City
country: United States
facility: Saint Lukes Hospital
state: Missouri
city: St. Louis
country: United States
facility: University of Washington St. Louis
state: Missouri
city: Asheville
country: United States
facility: Mission Hospital/Mission Neurology Services
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina Healthcare
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Neuro/The Moses H. Cone Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Falls Church
country: United States
facility: INOVA Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Linz
country: Austria
facility: AKH Linz
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Walter C Mackenzie Health Science Center
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Lille
country: France
facility: CHRU Lille-Hôpital Salengro
city: Aachen
country: Germany
facility: Neurologische Universitätsklinik Aachen
city: Bad Neustadt
country: Germany
facility: Neurologische Klinik Bad Neustadt
city: Berlin
country: Germany
facility: Charité Campus Berlin Mitte (CCM)
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus Bielefeld
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University of Düsseldorf
city: Erlangen
country: Germany
facility: Neurologische Universitätsklinik Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Johann Wolfgang Goethe-University
city: Frankfurt-Main
country: Germany
facility: Klinikum Frankfurt-Hochst
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Klinik und Poliklinik für Neurologie Leipzig
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Technische Universität München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Siegen
country: Germany
facility: Kreisklinikum Siegen GmbH
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Klinik GmbH
city: Lima
country: Peru
facility: Hospital Nacional Dos de Mayo
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario Albacete
city: Barcelona
country: Spain
facility: University Hospital Vall D'Hebron
city: Girona
country: Spain
facility: Hospital Universitari Dr Josep Trueta
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lidköping
country: Sweden
facility: Sjukhuset i Lidköping
city: Skövde
country: Sweden
facility: Kärnsjukhuset Skövde
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Heidelberg University
name: Werner Hacke, MD PhD
role: STUDY_CHAIR
affiliation: University of California, San Diego
name: Justin Zivin, MD PhD
role: STUDY_CHAIR
References:
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.