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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要意义：2021 年，美国有超过 75,000 人死于阿片类药物过量。治疗阿片类药物使用障碍 (OUD) 缺乏美国食品药品监督管理局 (FDA) 监管的设备 SBIR 第一阶段的目标是缓解药物渴望并防止药物滥用和药物过量。该项目是开发和测试一种便携式神经治疗设备，该设备可减少药物渴望过程创新：OUD 治疗后的渴望和药物使用是由患者的情绪引发的。对与先前吸毒有关的人、地点和事物的“注意偏见”例如，遭遇。药瓶可能会引起人们对其他与药物相关的线索的强烈关注，从而导致生理反应注意力偏差修正（ABM）是一种训练渴望和寻求药物行为的治疗方法。患者的注意力从药物使用的诱因（例如药瓶）转向自然的、非药物相关的 Neurotype Inc. 将开发 Modit-AB™，一种减少药物使用和过量服用的药物。使用闭环神经反馈和移动脑电图 (EEG) 的神经治疗设备具体目标 1：在 15 名健康对照者和 15 名受试者中使用耳机来改变 OUD 中与药物相关的注意力偏差。戒断 OUD 住院患者，我们将评估 3 种 ABM 与实时集成的技术可行性使用 Modit-AB™ 原型进行神经反馈这里展示了 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”共同设计方法来了解 Modit-AB™ 的看法和用户批评 (n = 10) 和患者 (n = 20) 来自参与 OUD 治疗计划的临床医生和患者反馈。预期成果：Modit-AB™ 的技术和商业可行性将是取决于其成功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（例如诊所办公室、候诊室）与 OUD 进行最后，我们将进行预提交。与 FDA 会面，澄清 Modit-AB ™的监管途径和 SBIR 二期项目的计划。研究人员： Neurotype Inc. 及其合作者团队包括临床神经科学、成瘾领域的专家医学、脑电图脑监测、产品开发、软件工程、医疗保健和监管很重要。