Transcranial Laser Therapy of Ischemic Stroke

描述(申请人提供)：虽然急性缺血性中风现在是一种可以治疗的疾病，但作为唯一被批准的方法，溶栓治疗还远远不是完美的，因为治疗窗口很短，而且存在显著的副作用(即脑出血[ICH])。即使用组织纤溶酶原激活剂(TPA)进行溶栓治疗，完全缓解症状的几率也不到40%，因此需要其他形式的治疗。许多神经保护策略已经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。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害。然而，传递能量的最佳方式还没有确定。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的安全性和有效性还没有得到任何实质性的评估。由于可以使用多种激光设置来实施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对脑出血的影响，因为许多缺血性中风都有出血成分。最后，由于tPA治疗是目前标准的中风治疗，TLT肯定会与溶栓剂联合使用。我们将进行联合研究，以确定tPA和TLT在联合应用时是否产生有益的效果。此外，由于tPA治疗最可怕的并发症是脑出血，我们将调查TLT是否改变了这种关系。总体而言，在这项研究计划中，我们将确定TLT的许多重要变量，以便该设备可以迅速开发用于治疗急性缺血性中风，而不是已经在进行的计划。 相关性：如果成功，这项计划将产生一种新的治疗形式，可以显著增加医生在中风发作后治疗中风患者的时间。由于这种疗法可能相当安全，因此很容易被大多数从业者采用。最后，经颅激光疗法还处于初级阶段，安全性和有效性的证明将显著加快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.