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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NeuroThera® Effectiveness and Safety Trial - 2 (NEST-2) A Double Blind, Randomized, Controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Effectiveness of the Treatment of Acute Ischemic Stroke With the NeuroThera® Laser System Within 24 Hours From Stroke Onset

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: NeuroThera® Laser System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Laser Therapy<br> | Device: NeuroThera® Laser System<br>* Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp<br>|
| Sham Comparator: Sham control procedure<br> | Device: NeuroThera® Laser System<br>* Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability scale (mRS)score at 90 days; safety of the treatment procedure |  | at baseline, day 5, 30, 60 and 90 post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional neurological scale(NIHSS)over time |  | at baseline, Day 5, 30, 60 and 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute stroke, infrared laser therapy, clinical trial, safety, effectiveness