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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhotoThera, Inc
ClinicalTrials.gov Identifier:
NCT01120301
First received: May 5, 2010
Last updated: November 14, 2013
Last verified: October 2012

May 5, 2010
November 14, 2013
September 2010
September 2012   (final data collection date for primary outcome measure)
  • Disability assessed using the dichotomous modified Rankin Scale (mRS) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Adverse event differences between transcranial laser therapy and sham [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01120301 on ClinicalTrials.gov Archive Site
  • Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Distribution of scores across the ordinal mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke
Device: NeuroThera® Laser System
Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
  • Experimental: Transcranial Laser Therapy
    Intervention: Device: NeuroThera® Laser System
  • Sham Comparator: Sham control procedure
    Intervention: Device: NeuroThera® Laser System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
Not Provided
September 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Finland,   France,   Germany,   Peru,   Spain,   Sweden,   Switzerland
 
NCT01120301
NTS-INT08-009
Yes
PhotoThera, Inc
PhotoThera, Inc
Not Provided
Study Chair: Werner Hacke, MD PhD Heidelberg University
Study Chair: Justin Zivin, MD PhD University of California, San Diego
PhotoThera, Inc
October 2012

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