Effectiveness and Safety Trial of a New Ischemic Stroke Treatment Within 24 Hours From Stroke Onset (NEST-2)

This study is a prospective, double blind, randomized, sham controlled, parallel group, multi-center study that will include enrollment of up to 660 Subjects. Subjects will be followed for 90 days post stroke onset. The primary effectiveness endpoint for this study will be the binary endpoint that defines success as a modified Rankin Scale (mRS) score of 0-2 and failure as an mRS score of 3-6 at 90 days or the last rating. The secondary effectiveness endpoint for this study will be the change in NIHSS score from baseline to 90 days or the last rating, analyzed across the full range of scores on the NIHSS. Tertiary effectiveness endpoints include: The 90-day binary endpoint, denoted as the 90-day bNIH score, based on the NIHSS score that defines a successful result as either (i) an improvement of 9 or more points on the NIHSS or (ii) a final NIHSS score of 0 or 1; the score on the mRS at 90 days or the last rating analyzed across the range of scores from 0 to 6 on the mRS scale, SIS-16 at 90 days; mortality at 30, 60 and 90 days.

Inclusion criteria

• Diagnosis of Acute Ischemic Stroke within 24 hours
• Clinical diagnosis of Acute Ischemic Stroke after exclusion of hemorrhage by a CT scan or susceptibility weighted MRI sequences
• NIHSS ≥7 - ≤22

Exclusion criteria

• >24hours from symptom onset to time of treatment
• Evidence of intracranial, subdural, or subarachnoid hemorrhage
• Clinical presentation of intracranial hemorrhage
• Pre stroke ≥3 mRS
• The presence of a brainstem or cerebellar stroke
• Transient Ischemic Attack (TIA)
• Seizure at stroke onset
• Blood glucose >400 or <60
• Sustained systolic BP >220mmHG < 80mmHG or diastolic >140mmHG <50mmHG
• Septic embolus
• CNS tumor (except asymptomatic meningioma)
• Dermatologic condition of the scalp (e.g. Psoriasis)
• Thrombolytic therapy
• Head implant (e.g. Clipped aneurysm, Hakim valve)