Closed-loop attention bias modification brain training for opioid use disorder

项目摘要/摘要 意义：2021年，美国有超过7.5万人死于阿片类药物过量。诊所 治疗阿片使用障碍(OUD)缺乏食品和药物管理局(FDA)监管的设备，可以 处方用于缓解食欲，防止药物使用和过量使用。此SBIR第一阶段的目标是 该项目是开发和测试一种便携式神经治疗设备，该设备可以通过使用 大脑训练。创新：治疗后的渴求和药物使用是由患者的 “注意力偏向”指的是与既往吸毒有关的人、地点和事物。例如，遇到 一个药瓶可能会唤起人们对其他与药物相关的线索的强烈关注，从而导致生理上的 渴求和寻求毒品的行为。注意偏差修正(ABM)是一种经过训练的治疗方法 患者的注意力从药物使用的诱因(例如，药瓶)转向自然的、与药物无关的 情景(例如，亲社会线索)、减少药物使用和过量用药。Neurotype Inc.将开发MODIT-AB™，一种 一种采用闭环神经反馈和移动脑电的神经治疗仪 耳机可以改变OUD中与药物相关的注意偏差。具体目标1：15名健康对照和15名 在住院戒酒患者中，我们将评估3种ABM结合实时的技术可行性 使用MODIT-AB™原型的神经反馈。这里，ABM神经反馈对神经行为的影响 将对注意力和注意力偏向的测量进行评估。具体目标2：我们将评估预期， 使用“未来研讨会”与临床医生共同设计的MODIT-AB™的认知和用户批评 10例患者和20例参加OUD治疗方案的患者。临床医生和患者的反馈将 导轨装置设计。预期结果：MODIT-AB™的技术和商业可行性将是 取决于它成功地改变患者与药物相关的注意力偏向和渴望过程的能力 在看护点(例如，诊所、候诊室)使用OUD。最后，我们将进行预提交 与美国食品和药物管理局开会，澄清MODIT-AB™的S调控途径和第二阶段项目计划。 调查人员：Neurotype Inc.及其合作者团队包括临床神经科学、成瘾方面的专家 医学、脑电大脑监测、产品开发、软件工程、医疗保健和监管 事情。

Project Summary / Abstract Significance: In 2021, more than 75,000 people in the United States died from opioid overdoses. Clinics that treat Opioid Use Disorder (OUD) lack Food and Drug Administration (FDA)-regulated devices that can be prescribed to alleviate cravings and prevent drug use and overdoses. The objective of this SBIR Phase I project is to develop and test a portable neurotherapeutic device that reduces drug craving processes using brain training. Innovation: Craving and drug use following OUD treatment are precipitated by patients’ “attention bias” towards people, places, and things associated with prior drug use. For example, encountering a pill bottle may evoke intensified attention towards additional drug-related cues, leading to physiological craving and drug-seeking behavior. Attention Bias Modification (ABM) is a therapeutic approach that trains patients’ attention away from triggers for drug use (e.g., pill bottle) and towards natural, non-drug-related scenarios (e.g., prosocial cues), curtailing drug use and overdose. Neurotype Inc. will develop Modit-AB™, a neurotherapeutic device that uses closed-loop neurofeedback and mobile electroencephalogram (EEG) headsets to modify drug-related attention biases in OUD. Specific aim 1: in 15 healthy controls and 15 abstinent OUD inpatients, we will evaluate the technical feasibility of 3 types of ABM integrated with real-time neurofeedback using the Modit-AB™ prototype. Here, the effects of ABM neurofeedback on neurobehavioral measures of attention and attention bias will be evaluated. Specific aim 2: we will assess the expectations, perceptions, and user criques of Modit-AB™ using a “Future Workshop” co-designing approach with clinicians (n = 10) and patients (n = 20) from participating OUD treatment programs. Clinician and patient feedback will guide device design. Expected outcomes: the technical and commercial feasibility of Modit-AB™ will be determined by its ability to successfully modify drug-related attention biases and craving processes in patients with OUD at the point of care (e.g., clinic office, waiting room). Finally, we will conduct a pre-submission meeting with the FDA to clarify Modit-AB™’s regulatory pathway and plan for the SBIR Phase II project. Investigators: Neurotype Inc. and its team of collaborators includes experts in clinical neuroscience, addiction medicine, EEG brain monitoring, product development, software engineering, healthcare, and regulatory matters.