On Demand Electrostimulation

按需电刺激

• 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
• 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

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。不仅有一个重要的 过量的风险，OUD患者的寿命比没有OUD的患者减少了约18年。 上瘾然而，与此同时，有三种FDA批准的药物可用于治疗OUD： 美沙酮丁丙诺啡和纳洛酮虽然这些药物有助于治疗OUD， 大多数患者没有经历长期缓解。我们的目标是开发一种治疗 OUD，使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），旨在刺激大脑区域， 与OUD有牵连以前的成像研究表明，前额叶皮层的部分是 与无法对寻求毒品的行为施加认知控制有关。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）。 先前的OUD影像学研究也表明，这些脑区在OUD中活动减退。因此，我们的目标 就是用ODE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 大脑模拟研究和使用人类头骨（作为幻影）来测量电场的实验室工作 由我们的电极产生。模拟研究将使用大脑模型进行， 与FDA合作开发用于器械开发。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一起制定完整的确认和验证计划。