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

项目总结/摘要 2021年，美国有超过75，000人死于阿片类药物过量。的诊所 治疗阿片类药物使用障碍（OUD）缺乏食品和药物管理局（FDA）监管的设备，可以 处方，以减轻渴望和防止药物使用和过量。SBIR第一阶段的目标 一个项目是开发和测试一种便携式神经治疗设备，使用 大脑训练创新：OUD治疗后的渴望和药物使用是由患者的 对与先前吸毒有关的人、地点和事物的"注意力偏差"。例如，遇到 药瓶可能会引起对其他药物相关线索的强烈关注，导致生理性 渴望和寻求毒品的行为。注意力偏差修正（ABM）是一种治疗方法， 使患者的注意力远离药物使用的触发因素（例如，药瓶）和走向自然，非药物相关 场景（例如，亲社会线索），减少药物使用和过量。神经型公司将开发Modit-AB ™， 使用闭环神经反馈和移动的脑电图（EEG）的神经治疗设备 头戴式耳机来改变OUD中与药物相关的注意力偏差。具体目标1：在15名健康对照和15名 对戒断OUD住院患者，我们将评估3种ABM与实时 使用Modit-AB ™原型的神经反馈。在这里，ABM神经反馈对神经行为的影响 将评估注意力和注意力偏差的测量。具体目标2：我们将评估期望， 使用"未来研讨会"与临床医生共同设计方法的Modit-AB ™的感知和用户评论 （n = 10）和参与OUD治疗计划的患者（n = 20）。临床医生和患者反馈将 引导装置设计预期成果：Modit-AB ™的技术和商业可行性 这取决于它成功地改变患者与药物相关的注意力偏差和渴望过程的能力 在护理点使用OUD（例如，诊所办公室、候诊室）。最后，我们将进行预提交 与FDA会面，以澄清Modit-AB ™的监管途径和SBIR第二阶段项目的计划。 研究者：Neurotype Inc.其合作者团队包括临床神经科学、成瘾 医学、EEG脑监测、产品开发、软件工程、医疗保健和监管 事项.

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.