The purpose of this pivotal study is to demonstrate safety and effectiveness of the NeuroThera® Laser System (referred to hereafter as NTS) in the treatment of Subjects diagnosed with acute ischemic stroke. The initiation of NTS treatment must be feasible for each Subject within 24 hours of stroke onset.
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.
- NeuroThera Laser System (NTS) Other
Intervention Desc: Treatment with light.
- NeuroThera® Laser System Device
Intervention Desc: Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp ARM 1: Kind: Experimental Label: Transcranial Laser Therapy ARM 2: Kind: Experimental Label: Sham control procedure
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
CT scan at diagnosis; treatment with NeuroThera Laser System; mRS score and NIHSS score at 30, 60, and 90 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Disability scale (mRS)score at 90 days; safety of the treatment procedure.|
|Secondary||Functional neurological scale(NIHSS)over time.|
|Primary||Disability scale (mRS)score at 90 days; safety of the treatment procedure||at baseline, day 5, 30, 60 and 90 post treatment||Yes|
|Secondary||Functional neurological scale(NIHSS)over time||at baseline, Day 5, 30, 60 and 90||No|
- PhotoThera, Inc Lead