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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PhotoThera, Inc
ClinicalTrials.gov Identifier:
NCT01120301
First received: May 5, 2010
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
 Device: NeuroThera® Laser System
 Phase 3

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
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

Further study details as provided by PhotoThera, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: September 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120301

  Show 60 Study Locations
Sponsors and Collaborators
PhotoThera, Inc
Investigators
Study Chair: Werner Hacke, MD PhD Heidelberg University
Study Chair: Justin Zivin, MD PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: PhotoThera, Inc
ClinicalTrials.gov Identifier: NCT01120301     History of Changes
Other Study ID Numbers: NTS-INT08-009
Study First Received: May 5, 2010
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
Finland: National Supervisory Authority for Welfare and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: German Institute of Medical Documentation and Information
Peru: Instituto Nacional de Salud
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Switzerland: Swissmedic

Keywords provided by PhotoThera, Inc:
stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013