On Demand Electrostimulation

项目总结： 阿片类药物使用障碍(OUD)是最致命的成瘾。不仅是因为有显著的 过量服药的风险：与没有服药的患者相比，患有尿毒症的患者的寿命缩短了约18年。 一种瘾。然而，与此同时，FDA批准的三种药物可用于治疗OUD： 美沙酮、丁丙诺啡和纳曲酮。虽然这些药物对治疗OUD有帮助，但 大多数患者不会经历长期的缓解。我们的目标是开发一种辅助治疗 OUD，使用脑刺激来提高治疗反应。 我们的设备名为按需电刺激(ODE)，旨在刺激大脑中具有 与奥德有牵连。之前的成像研究表明，前额叶皮质的部分是 与无法对寻求毒品行为施加认知控制有关。这些地区包括 背外侧前额叶皮质(DlPFC)、背内侧前额叶皮质(DmPFC)和前扣带回(ACC)。 之前在OUD中的成像研究也表明，OUD中的这些脑区活动不足。因此，我们的目标是 就是用颂歌来刺激这些大脑区域。 在第一阶段的应用中，我们描述了开发ODE所需的初始步骤。这包括 使用人类头骨(作为体模)来测量电场的大脑模拟研究和工作台工作 由我们的电极产生。模拟研究将使用一个大脑模型进行，该模型 与FDA合作开发的设备。头骨研究将用于调查 电极本身产生的刺激程度。在第一阶段结束时，我们的目标是 与FDA一起制定完整的验证和验证计划。

PROJECT SUMMARY: Opioid Use Disorder (OUD) stands out as being the most lethal of addictions. Not only is there a significant risk of overdose, the life span of a patient with OUD decreased by about 18 years compared to those without an addiction. Yet, at the same time, there are three FDA approved medications available to treat OUD: methadone, buprenorphine, and naltrexone. While these medications are helpful for treating OUD, the majority of patients do not experience long term remission. Our goal is to develop an adjunctive treatment for OUD, using brain stimulation to improve treatment response. Our device, called On-Demand Electrostimulation (ODE) is designed to stimulate the brain regions that have been implicated in OUD. Previous imaging studies show that the sections of the prefrontal cortex are associated with inability to exert cognitive control over drug seeking behavior. These regions include the dorsolateral prefrontal cortex (dlPFC), dorsomedial prefrontal cortex (dmPFC), and anterior cingulate (ACC). Previous imaging studies in OUD also show that these brain regions are hypoactive in OUD. Thus, our goal is to stimulate these brain regions using ODE. In this phase one application, we delineate the initial steps needed for the development of ODE. This includes brain simulation studies and bench work using human skulls (as phantoms) to measure the electrical field generated by our electrodes. The simulation studies will be performed using a brain model that was developed in collaboration with the FDA for device development. The skull studies will be used to investigate the degree of stimulation generated by the electrodes themselves. At the end of phase one, our goal is to have a completed validation and verification plan in place with the FDA.