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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01120301
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
PhotoThera, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Device: NeuroThera® Laser System Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Transcranial Laser Therapy Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Sham Comparator: Sham control procedure Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp


Outcome Measures
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Primary Outcome Measures :
  1. Disability assessed using the dichotomous modified Rankin Scale (mRS) [ Time Frame: Day 90 ]
  2. Adverse event differences between transcranial laser therapy and sham [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ]
  2. Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) [ Time Frame: Day 90 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120301


Locations
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Sponsors and Collaborators
PhotoThera, Inc
Investigators
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Study Chair: Werner Hacke, MD PhD Heidelberg University
Study Chair: Justin Zivin, MD PhD University of California, San Diego
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PhotoThera, Inc
ClinicalTrials.gov Identifier: NCT01120301    
Other Study ID Numbers: NTS-INT08-009
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: October 2012
Keywords provided by PhotoThera, Inc:
stroke
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases