MedTrace Logo

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

NCT01120301 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2013-11-15

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke

Interventions

DEVICE

NeuroThera® Laser System

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

Sponsors & Collaborators

  • PhotoThera, Inc

    lead INDUSTRY

Principal Investigators

  • Werner Hacke, MD PhD · Heidelberg University

  • Justin Zivin, MD PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-09-30

Countries

  • United States
  • Austria
  • Canada
  • Finland
  • France
  • Germany
  • Peru
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120301 on ClinicalTrials.gov