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

PhotoThera, Inc59 sites in 7 countries1,000 target enrollmentSeptember 2010

ConditionsAcute Ischemic Stroke

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: PhotoThera, Inc
Enrollment: 1000
Locations: 59
Primary Endpoint: Adverse event differences between transcranial laser therapy and sham
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PhotoThera, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of acute ischemic stroke
•Subject is not a candidate for treatment with neurothrombectomy
•Initiation of the TLT procedure begins between 4.5 and 24 hours
•Baseline NIHSS score range: 7-17
•Full functional independence just prior to the present stroke episode
•Negative pregnancy test in females of childbearing potential
•Subject Informed Consent obtained prior to enrollment into this study

Exclusion Criteria

•Evidence of an intracranial, subdural, or subarachnoid hemorrhage
•Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes
•Seizure at stroke onset or within the 7 days prior to stroke onset
•Sustained blood glucose \>300 or \<60 mg/dl
•Sustained hypertension (SBP \>220 mmHg or DBP \>140 mmHg)
•Sustained hypotension (SBP \<80 mmHg or DBP \<50 mmHg)
•A presumed and/or confirmed septic embolus
•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.
•Head implant of any kind
•Significant skin condition of the scalp (eg. psoriasis)