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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

Tracking Information
First Submitted Date  ICMJE May 5, 2010
First Posted Date  ICMJE May 10, 2010
Last Update Posted Date November 15, 2013
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
  • Disability assessed using the dichotomous modified Rankin Scale (mRS) [ Time Frame: Day 90 ]
  • Adverse event differences between transcranial laser therapy and sham [ Time Frame: Day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ]
  • Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) [ Time Frame: Day 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
Study Arms  ICMJE
  • Experimental: Transcranial Laser Therapy
    Intervention: Device: NeuroThera® Laser System
  • Sham Comparator: Sham control procedure
    Intervention: Device: NeuroThera® Laser System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 6, 2010)
1000
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Finland,   France,   Germany,   Peru,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01120301
Other Study ID Numbers  ICMJE NTS-INT08-009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PhotoThera, Inc
Study Sponsor  ICMJE PhotoThera, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Werner Hacke, MD PhD Heidelberg University
Study Chair: Justin Zivin, MD PhD University of California, San Diego
PRS Account PhotoThera, Inc
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP