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

This study has been terminated.
(Device sponsor no longer in business.)
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Justin Zivin, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01220739
First received: October 13, 2010
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Intervention: Device: Transcranial Laser Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sham Transcranial Laser Therapy

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

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.

Transcranial Laser Therapy

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

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.


Participant Flow:   Overall Study
    Sham Transcranial Laser Therapy   Transcranial Laser Therapy
STARTED   7   5 
COMPLETED   7   5 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sham Transcranial Laser Therapy

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

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.

Transcranial Laser Therapy

Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.

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.

Total Total of all reporting groups

Baseline Measures
   Sham Transcranial Laser Therapy   Transcranial Laser Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   5   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (8.5)   66.8  (12.7)   65.2  (10.0) 
Gender 
[Units: Participants]
     
Female   3   2   5 
Male   4   3   7 
Randomization NIH Stroke Scale [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 12.3  (3.2)   15.0  (2.4)   13.4  (3.1) 
[1] Total score is reported. Minimum score = 0 (better outcome); Maximum score = 42 (worse outcome)
Post-tPA Baseline/Treatment NIH Stroke Scale [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 8.7  (5.4)   9.6  (5.4)   9.1  (5.2) 
[1] Total score is reported. Minimum score = 0 (better outcome); Maximum score = 42 (worse outcome)


  Outcome Measures
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1.  Primary:   Symptomatic Intracranial Hemorrhages   [ Time Frame: 36 hours from tPA initiation ]

2.  Primary:   Percentage of Participants With Modified Rankin Scale (0 - 1)   [ Time Frame: 90 Days from Stroke Onset ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early due to device sponsor filing bankruptcy.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas Hemmen
Organization: University of California, San Diego
phone: 858-657-7190
e-mail: themmen@ucsd.edu


Publications:

Responsible Party: Justin Zivin, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01220739     History of Changes
Other Study ID Numbers: StELLAR
P50NS044148 ( US NIH Grant/Contract Award Number )
Study First Received: October 13, 2010
Results First Received: December 3, 2014
Last Updated: October 7, 2016
Health Authority: United States: Food and Drug Administration