Intranasal Infrared Light Therapy

• Cerebral Apoplexy
• Cerebral Thrombosis And Cerebral Embolism
• Cerebral Infarction
• Brain Arterial Occlusion

1. No adverse reactions, completely non-invasive.

2. Compact and portable design allows for convenient use anywhere.

3. Only plug in, then the laser will output automatically.

4. superior quality.

5. No need for a main unit; simply connect directly to a power source.

6. Backed by rigorous clinical trials and certified by CFDA and CE for assurance of effectiveness.

Perhaps the most well-investigated application of PBM to the brain, lies in its possible use as a treatment for acute stroke. Animal models such as rats and rabbits, were first used as laboratory models, and these animals had experimental strokes induced by a variety of methods and were then treated with light (usually 810 nm laser) within 24 h of stroke onset. In these studies intervention by low intensity laser light therapy within 24 h had meaningful beneficial effects. For the rat models, stroke was induced by middle cerebral artery occlusion (MCAO) via an insertion of a filament into the carotid artery or via craniotomy. Stroke induction in the "rabbit small clot embolic model" (RSCEM) was by injection of a preparation of small blood clots (made from blood taken from a second donor rabbit) into a catheter placed in the right internal carotid artery.

Abstract

Background and Purpose: Effectiveness and Safety Trial-1 (NEST-1) examined the safety and preliminary effectiveness of the Laser System in enhancing 90-day outcomes for ischemic stroke patients treated within 24 hours of stroke onset. This therapeutic approach utilizes infrared laser technology, which has shown significant and sustained benefits in animal models of ischemic stroke.



Methods:This prospective, intention-to-treat, multicenter, international, double-blind trial included 120 ischemic stroke patients. Participants were randomized in a 2:1 ratio, with 79 patients in the active treatment group and 41 in the sham (placebo) control group. Patients with baseline stroke severity, measured by the National Institutes of Health Stroke Scale (NIHSS) scores of 7 to 22, were eligible, excluding those who received tissue plasminogen activator. Outcome measures included NIHSS, modified Rankin Scale (mRS), Barthel Index, and Glasgow Outcome Scale scores at 90 days post-treatment. The primary outcome was successful treatment, defined by a complete recovery (NIHSS 0 to 1) or a decrease of at least 9 points in NIHSS score from baseline to day 90. Secondary outcomes included mRS, Barthel Index, and Glasgow Outcome Scale scores. Primary statistical analyses used the Cochran-Mantel-Haenszel rank test, stratified by baseline NIHSS score and time to treatment for the bNIH and mRS, with logistic regression analyses conducted to validate the results.



Results:The mean time to treatment was over 16 hours, with a median of 18 hours for the active group and 17 hours for the control group, ranging from 2 to 24 hours. A higher percentage of patients in the active treatment group (70%) achieved successful outcomes compared to controls (51%) as measured by bNIH (P=0.035 stratified by severity and time to treatment; P=0.048 stratified by severity alone). Similarly, 59% of the active treatment group had successful outcomes compared to 44% of controls, as measured by a binary mRS score of 0 to 2 at 90 days (P=0.034 stratified by severity and time to treatment; P=0.043 stratified by severity alone). Additionally, the active treatment group showed more favorable changes in mean NIHSS scores from baseline to 90 days (P=0.021 stratified by time to treatment) and full mRS scores (P=0.020 stratified by severity and time to treatment; P=0.026 stratified by severity alone). The prevalence odds ratio for bNIH was 1.40 (95% CI, 1.01 to 1.93) and for binary mRS was 1.38 (95% CI, 1.03 to 1.83), adjusting for baseline severity. Similar results were found for the Barthel Index and Glasgow Outcome Scale. Mortality rates and serious adverse events did not significantly differ between the active (8.9% mortality and 25.3% SAEs) and control groups (9.8% mortality and 36.6% SAEs).



Conclusions: The NEST-1 study suggests that infrared laser therapy is initially safe and effective for treating ischemic stroke in humans when administered within 24 hours of stroke onset. Further, larger trials are needed to confirm these findings.