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

针对阿片类药物使用障碍的闭环注意偏差修正大脑训练

• 批准号: 10699099
• 负责人: Scott Burwell
• 金额: $ 32.67万
• 依托单位: NEUROTYPE INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699099
• 关键词: Attention; Awareness; Brain; Clinic; Clinical; Clinical Trials; Critiques; Cues; Data Collection; Device Designs; Devices; Drug usage; Educational workshop; Effectiveness; Electroencephalography; Environment; Feedback; Future; Healthcare; Innovation Corps; Inpatients; Intervention; Learning; Magnetic Resonance Imaging; Measures; Medicine; Mental Depression; Modification; Monitor; Neurocognitive; Neurosciences; Opioid; Outcome; Overdose; Participant; Patient Education; Patient-Centered Care; Patients; Perception; Persons; Pharmaceutical Preparations; Phase; Physiological; Process; Regulatory Pathway; Relapse; Research Personnel; Rewards; Safety; Small Business Innovation Research Grant; Software Engineering; Stimulus; Suggestion; System; Task Performances; Techniques; Technology Assessment; Testing; Therapeutic; Time; Training; United States; United States Food and Drug Administration; United States National Institutes of Health; Visual; addiction; attentional bias; cost; craving; design; detection platform; digital treatment; drug abuse prevention; drug craving; drug modification; drug seeking behavior; expectation; experience; feasibility testing; improved; innovation; meetings; neurobehavioral; neurofeedback; non-drug; novel; opioid overdose; opioid use disorder; pill; point of care; portability; prevent; product development; programs; prototype; sensor technology; success; treatment program

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.

项目摘要 /摘要 意义：2021年，美国有75,000多人死于阿片类药物过量。诊所 治疗阿片类药物使用障碍（OUD）缺乏食品药物管理（FDA）调节的设备 规定以减轻渴望并防止吸毒和过量服用。 SBIR I期的目的 项目将开发和测试一种便携式神经治疗装置，该设备可减少使用药物的渴望过程 脑训练。创新：渴望和在Oud治疗后使用毒品是珍贵的 对人，地方和与先前使用毒品相关的事物的“注意力偏见”。例如，遇到 药瓶可能会引起人们对其他与药物有关的提示的加剧，从而导致物理 渴望和寻求毒品的行为。注意偏见修改（ABM）是一种训练的治疗方法 患者的注意力远离吸毒的触发因素（例如，药瓶）和与自然，无药有关 场景（例如，亲社会提示），减少药物使用和过量。 Neurotype Inc.将开发Modit-AB™，一个 使用闭环神经反馈和移动脑电图（EEG）的神经治疗装置 耳机可修改与药物相关的注意力偏见。特定目标1：在15个健康对照和15个中 避免住院官，我们将评估与实时集成的3种ABM类型的技术可行性 使用MODIT-AB™原型进行神经反馈。在这里，ABM神经反馈​​对Neurobehavioral的影响 将评估注意力和注意力偏见的措施。特定目标2：我们将评估期望， 使用临床医生的“未来研讨会”的共同设计方法，对MODIT-AB™的看法和用户criques （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 指南设备设计。预期结果：MODIT-AB™的技术和商业可行性将是 取决于其成功改变药物相关的注意偏见和渴望过程的能力 在护理点上（例如，诊所，候诊室）。最后，我们将进行预审 与FDA会面，以阐明Modit-AB™的监管途径和SBIR II期项目的计划。 调查人员：Neurotype Inc.及其合作者团队包括临床神经科学，成瘾专家 医学，脑电图大脑监测，产品开发，软件工程，医疗保健和监管 很重要。