Transcranial Laser Therapy of Ischemic Stroke

描述（由申请人提供）：尽管急性缺血性卒中现在是一种可治疗的疾病，但溶栓是唯一获批的方法，由于治疗时间窗短和显著的副作用问题（即脑出血[ICH]），因此远非完美。即使使用组织型纤溶酶原激活剂（tPA）进行溶栓治疗，症状完全缓解的时间也不到40%，因此需要其他形式的治疗。许多神经保护策略已在临床试验中进行了测试，但这些方法尚未被FDA批准用于治疗缺血性中风。 低能量红外线照射的经颅激光治疗（TLT）是一种电磁能量，能够穿透大脑并与组织发生反应，产生一系列生化反应。来自我们实验室的初步数据提供了证据，证明TLT可以减少栓塞性中风兔模型的神经损伤。然而，提供能量的最佳方式尚未确定。 这些拟议的实验有三个主要目标。首先，尽管TLT可以改善行为功能，但TLT的安全性和有效性尚未在任何实质性程度上进行评估。由于多种激光设置可用于管理TLT，我们将系统地改变功率密度、治疗持续时间、占空比和重复治疗。我们还将确定TLT对ICH的影响，因为许多缺血性卒中都有出血成分。最后，由于tPA治疗是目前标准的卒中治疗，因此可以肯定的是，TLT将与溶栓药物联合使用。我们将进行联合研究，以确定tPA和TLT联合给药时是否产生有益效果。此外，由于tPA治疗最可怕的并发症是ICH，我们将研究TLT是否改变了这种关系。 总体而言，在本研究项目中，我们将确定TLT的许多重要变量，以便该器械可以快速开发用于治疗急性缺血性卒中，超出正在进行的计划。 相关性：如果成功的话，这个项目将产生一种新的治疗方法，可以显著增加医生在中风发作后治疗中风患者的时间。由于这种治疗方法可能相当安全，因此大多数从业者都很容易采用。最后，经颅激光治疗尚处于起步阶段，安全性和有效性的证明将显著加速其在各种疾病中的发展。

DESCRIPTION (provided by applicant): Although acute ischemic stroke is now a treatable condition, thrombolysis, which is the only approved method, is far from perfect because of a short therapeutic window and significant side effect concerns (i.e. intracerebral hemorrhage [ICH]). Even thrombolytic therapy with tissue plasminogen activator (tPA) produces complete resolution of symptoms less than 40% of the time, so there is need for additional forms of therapy. Numerous neuroprotective strategies have been tested in clinical trials, but these methods have not been approved by the FDA for treating ischemic stroke. Transcranial laser therapy (TLT) with low energy infrared irradiation is a form of electromagnetic energy that is able to penetrate into the brain and react with the tissue to produce a series of biochemical reactions. Preliminary data from our laboratory provides evidence that TLT can reduce neurological damage in a rabbit model of embolic stroke. However, the best ways to deliver the energy have not been identified. There are three main objectives of these proposed experiments. First, even though TLT can improve behavioral function, the safety and efficacy profile of TLT has not been evaluated to any substantial extent. Since a wide variety of laser settings can be used to administer TLT, we will systematically alter power density, treatment duration, duty cycle and repeated therapy. We will also determine the effects of TLT on ICH because many ischemic strokes have a hemorrhagic component. Finally, since tPA therapy is the current standard stroke care, it is certain that TLT will be administered in combination with the thrombolytic. We will conduct combination studies to see if tPA and TLT produce beneficial effects when co-administered. Also, since the most feared complication of tPA therapy is ICH, we will investigate whether the TLT alters this relationship. Overall, in this research program, we will identify many important variables of TLT so that the device may be rapidly developed for the treatment of acute ischemic stroke beyond plans already in progress. RELEVANCE: If successful, this program will produce a new form of therapy that will be available to markedly increase the time that physicians will have to treat stroke victims after stroke onset. Since the treatment is probably quite safe, it will be readily adopted by most practitioners. Finally, transcranial laser therapy is in its infancy, and proof of safety and efficacy will markedly accelerate its development for a wide variety of disorders.