Safety of Rt-PA + Transcranial Emission of Low-Energy Lasers for Acute Stroke Recovery
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Transcranial Laser Therapy
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ischemic stroke; transcranial laser; tissue plasminogen activator; therapy

Summary:

      To assess the safety and preliminary efficacy of combining intravenous rt-PA with
      transcranial laser therapy (TLT) with the NeuroThera® Laser System (referred to hereafter as
      NTS) in subjects treated for acute ischemic stroke. Treatment with IV rt-PA must begin within
      3 hours of symptom onset, and the initiation of TLT procedure must be feasible for each
      subject within 6 hours of stroke onset. The NeuroThera® Laser System is an investigational
      device that provides noninvasive transcranial laser therapy to subjects diagnosed with acute
      ischemic stroke. The wavelength of the laser light is in the infrared zone of the
      electromagnetic spectrum and is invisible to the naked eye.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects may be included in the study only if they meet all of the following criteria:

          1. Subject is at least 40 years of age at screening, but has not had their 81st birthday.

          2. Subject has received IV rt-PA per the NINDS rt-PA Protocol Guidelines within 3 hours
             of symptom onset for an acute ischemic stroke.

          3. Subject is diagnosed with acute ischemic stroke and presents to the health care
             facility at a time such that initiation of NTS procedure is feasible within 6 hours of
             the time of stroke onset. The time of stroke onset is defined as the time at which a
             change in the baseline neurological function occurred. If the time is not known (e.g.,
             the subject awakens from sleep with new symptoms), the last time the patient was
             observed to be neurologically intact must be considered to be the time of onset.

          4. Documented baseline NIHSS score of > 7 and < 17 prior to IV rt-PA administration.
             Subjects who transfer from other facilities after receiving IV rt-PA must have a
             documented NIHSS by a certified examiner prior to initiation of rt-PA treatment.
             Documentation of NIHSS score via telemedicine is acceptable if performed by a
             certified examiner. Subjects who improve prior to NTS procedure will still be treated,
             unless their NIHSS improves to 0.

          5. Full functional independence just prior to the present stroke episode as defined by
             the following criteria:

               -  Estimated prestroke mRS score 0 or 1.

               -  Ambulates independently, may need a cane or walker, but does not need the
                  assistance of another person.

               -  Absence of a medical/physical/mental condition that substantially limits the
                  subject's ability to work, study, participate in leisure activities, or look
                  after family at home

               -  Completely independent, does not need supervision (may live with other
                  individuals, but could live alone if necessary)

          6. Negative serum or urine pregnancy test in females of childbearing potential.

          7. Subject (or legally authorized representative) provides written Informed Consent in
             compliance with local regulations prior to enrollment into this study.

          8. The subject (and caregiver, if applicable) is willing to participate in this study for
             at least 90 days after the onset of stroke.-

        Exclusion Criteria:

          1. Evidence on from a pre-tPA head CT of an intracranial, subdural, or subarachnoid
             hemorrhage or clinical presentation suggestive of subarachnoid hemorrhage even if the
             initial neuroimaging scan is normal.

          2. Clinical presentation consistent with a brainstem or cerebellar stroke

          3. A rapidly improving neurological status that in the opinion of the investigator will
             make the subject unsuitable for participation in this study or patient rapidly
             improves to NIHSS of 0 by start of NTS procedure.

          4. The subject had a seizure at stroke onset or within the 7 days prior to stroke onset.

          5. Sustained blood glucose > 300 mg/dl or < 60 mg/dl

          6. Subjects who, on repeated measurement, have a systolic blood pressure > 185, or a
             diastolic blood pressure > 110mmHg, post rt-PA administration, or it is the opinion of
             the investigator that aggressive treatment to reduce blood pressure post thrombolysis
             is required to keep pressure within these limits.

          7. Presumed and/or confirmed septic embolus.

          8. The subject has a history of CNS vascular wall disease (e.g. aneurysm, AVM).

          9. The subject has a history of CNS disease or damage (e.g. neoplasm or dementia) which
             may influence the subject's outcome assessment.

         10. The subject has a significant skin condition (i.e., hemangioma, scleroderma,
             psoriasis, rash, open wound or tattoo) on their scalp that is found to be directly
             below three or more TLT procedure sites.

         11. Planned or actual use of any intra-arterial thrombolytic medication or a clot
             retrieval device, or any diagnostic or therapeutic interventional neurovascular
             procedure, including mechanical recanalization, whether successful or unsuccessful,
             during this stroke episode.

         12. Subject previously participated in another investigational drug or device trial within
             the preceding four weeks.

         13. Subject is a female who is pregnant or lactating (within the previous 30 days),or who
             is of child-bearing potential unless she is surgically sterile or she and/or her
             partner are using a medically acceptable method of birth control.

         14. The subject has an implant of any kind in the head (i.e. clipped aneurysm, embolised
             AVM, implantable shunt - Hakim valve).

         15. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study
             enrollment.

         16. The subject participated in the NEST-1, NEST-2, or NEST-3 Study.

         17. The subject has any co-existing or terminal disease that may limit life expectancy or
             any medical condition (e.g. morbid obesity, substance abuse) that may, in the clinical
             judgment of the Investigator, independently influence the subject's outcome during the
             course of the study.

         18. The subject is otherwise determined, based on the opinion of the Investigator,to be an
             unsuitable candidate for enrollment in this study. -