On Demand Electrostimulation

按需电刺激

基本信息

批准号：
10390902
负责人：
Howard Levin
金额：
$ 22.39万
依托单位：
CORIDEA, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2023-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10390902
关键词：
Adherence Amygdaloid structure Anatomic Models Anatomy Animal Model Anterior Anxiety Architecture Brain Brain imaging Brain region Buprenorphine Clinic Collaborations Computer Models Data Decision Making Development Device or Instrument Development Devices Disease Disease remission Drug usage Electric Stimulation Electrodes Elements Ensure FDA approved Frontal bone structure Goals Hearing Aids Heroin Hippocampus (Brain)Human Human Volunteers Implant Impulsivity Lead Location Longevity Measures Medical Medicine Memory Loss Meninges Methadone Modeling Motor Cortex Movement Multimodal Imaging Naltrexone Opioid Pathway interactions Patients Pattern Pharmaceutical Preparations Phase Prefrontal Cortex Scalp structure Sepharose Shapes Structure System Time Transcranial magnetic stimulation Work addiction base bone brain parenchyma brain tissue cognitive control cranium craving data modeling design drug seeking behavior electric field electric impedance imaging study improved laboratory experiment mechanical properties medication-assisted treatment novel novel strategies opioid use opioid use disorder overdose risk prototype response side effect simulation theories treatment response verification and validation ward

项目摘要

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.

项目概要：阿片类药物使用障碍 (OUD) 是最致命的成瘾行为。不仅有重大意义服用过量的风险，与没有服用 OUD 的患者相比，患有 OUD 的患者的寿命减少了约 18 年一种瘾。然而，与此同时，FDA 批准了三种药物可用于治疗 OUD：美沙酮、丁丙诺啡和纳曲酮。虽然这些药物有助于治疗 OUD，但大多数患者没有获得长期缓解。我们的目标是开发一种辅助治疗方法 OUD，利用大脑刺激来改善治疗反应。我们的设备称为按需电刺激 (ODE)，旨在刺激具有以下功能的大脑区域：受到 OUD 的牵连。先前的影像学研究表明，前额皮质的部分是与无法对药物寻求行为进行认知控制有关。这些地区包括背外侧前额叶皮层 (dlPFC)、背内侧前额叶皮层 (dmPFC) 和前扣带回 (ACC)。之前对 OUD 的影像学研究也表明，这些大脑区域在 OUD 中活性低下。因此，我们的目标就是使用 ODE 来刺激这些大脑区域。在此第一阶段应用程序中，我们描述了开发 ODE 所需的初始步骤。这包括使用人类头骨（作为模型）测量电场的大脑模拟研究和实验室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与 FDA 合作开发用于设备开发。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 制定完整的验证和验证计划。