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

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.