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

Study Overview
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Brief Summary
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The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

Official Title
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NeuroThera® Efficacy and Safety Trial - 3 (NEST-3) A Double-blind, Randomized, Sham-controlled, Parallel Group, Multicenter, Pivotal Study to Assess the Safety and Efficacy of Transcranial Laser Therapy With the NeuroThera® Laser System for the Treatment of Acute Ischemic Stroke Within 24 Hours of Stroke Onset

Conditions
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Acute 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: Clinical diagnosis of acute ischemic stroke Subject is not a candidate for treatment with neurothrombectomy Initiation of the TLT procedure begins between 4.5 and 24 hours Baseline NIHSS score range: 7-17 Full functional independence just prior to the present stroke episode Negative pregnancy test in females of childbearing potential Subject Informed Consent obtained prior to enrollment into this study Exclusion Criteria: Evidence of an intracranial, subdural, or subarachnoid hemorrhage Acute ischemic strokes located exclusively in the brainstem, or cerebellum, or small deep infarctions, or massive hemispheric strokes Seizure at stroke onset or within the 7 days prior to stroke onset Sustained blood glucose >300 or <60 mg/dl Sustained hypertension (SBP >220 mmHg or DBP >140 mmHg) Sustained hypotension (SBP <80 mmHg or DBP <50 mmHg) A presumed and/or confirmed septic embolus 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. Head implant of any kind Significant skin condition of the scalp (eg. psoriasis) Use of any intravenous or intra-arterial thrombolytic medication Use of any diagnostic or therapeutic interventional neurovascular procedure Female who is pregnant or lactating or who is of childbearing potential and not using a medically acceptable method of birth control.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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 assessed using the dichotomous modified Rankin Scale (mRS) |  | Day 90 | 
| Adverse event differences between transcranial laser therapy and sham |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of scores across the ordinal mRS |  | Day 90 | 
| Binary outcome measure of the National Institute of Health Stroke Scale (bNIH) |  | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke