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Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery

NCT01220739 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-12-05

Study results available
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Summary

To assess the safety and preliminary efficacy of combining intravenous rt-PA with transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within 3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute ischemic stroke. The wavelength of the laser light is in the infrared zone of the electromagnetic spectrum and is invisible to the naked eye.

Conditions

Interventions

DEVICE

Transcranial Laser Therapy

Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site.

Sponsors & Collaborators

Principal Investigators

  • Thomas Hemmen, MD, PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01220739 on ClinicalTrials.gov