Mobile brain sensing platform for detection of opioid craving and treatment response

项目总结/摘要 超过200万美国人患有阿片类药物使用障碍（OUD），并在治疗后复发 超过60%，强调需要了解在开放式发展干预中什么“有效”（什么无效）。 目前，没有标准化的、客观的护理点工具来告知治疗提供者患者的健康状况。 阿片类药物渴望和复发脆弱性的水平，使主观和不清楚治疗的有效性， 减少烟瘾和防止复发。这些不足之处助长了代价高昂的长期循环， 复发、急诊室就诊、法律的问题、重新入院治疗、过量用药和可能的死亡 OUD患者的经验。创新：使用消费级移动的脑电图（EEG） 耳机和专有软件，Neurotype Inc.建议开发和商业化 NeuromarkR™，一种能够检测EEG线索反应性相关性的床旁脑传感平台 以及吸毒和复吸的预期指标。NeuromarkR可用于EEG非 专家（例如，临床医生，技术人员），以量化阿片类药物渴求的生物标志物相关性，基准治疗 有效性，并可能为治疗决策提供信息。NeuromarkR平台：1）采集患者的EEG 在查看情感（充满情感）和阿片类药物相关图像期间，2）执行全自动EEG信号 处理和线索反应性量化，以及3）生成阿片样物质线索反应性的数字报告 可以纵向测量以客观量化治疗终点的表型（例如，渴望 减少，药物线索反应性的变化）。具体目标：SBIR第一阶段项目有两个目标， 包括：1）测量和纵向跟踪渴望和EEG线索反应表型， 寻求治疗的OUD患者超过48周的恢复，以及2）我们的NeuromarkR原型的开发 转化为一个可扩展的网络平台，用于在护理点生成临床见解和报告。预计 结果：成功的项目结果包括：1）鉴定药物线索反应性表型（例如，EEG 对阿片样物质线索的反应类似于对自然奖励线索的EEG反应）， 与恢复结果相关（例如，治疗完成，延长禁欲，减少渴望），和2） 一个成熟的网络平台，使更广泛的临床和研究使用。最后，我们将获得反馈 关键利益相关者（例如，临床医生、患者），并与食品药品监督管理局（FDA） 政府当局须修订第二期工程的规管计划。调查人员：我们的团队包括专家 在临床药物滥用治疗，成瘾神经科学，脑电图大脑监测，软件工程， 和健康技术创业发展的专业知识。

Project Summary/Abstract Significance: Over 2 million Americans have an Opioid Use Disorder (OUD) and relapse following treatment exceeds 60%, underlining a need to understand what “works” (and what does not) in OUD interventions. Currently, there are no standardized, objective point of care tools to inform treatment providers of patients’ level of opioid craving and relapse vulnerability, leaving subjective and unclear a treatment’s effectiveness on reducing craving and protecting against relapse. Such inadequacies contribute to the costly and chronic cycle of relapse, emergency room visits, legal problems, treatment re-admittance, overdose, and possible death experienced by OUD patients. Innovation: Using consumer-grade mobile electroencephalogram (EEG) headsets and proprietary software, Neurotype Inc. proposes development and commercialization of NeuromarkR™, a point of care brain-sensing platform that enables detection of EEG cue reactivity correlates of drug craving and prospective indicators of drug use and relapse. NeuromarkR may be used by EEG non- experts (e.g., clinicians, technicians) to quantify biomarker correlates of opioid craving, benchmark treatment effectiveness, and potentially inform treatment decisions. The NeuromarkR platform: 1) acquires patients’ EEG during viewing of affective (emotion-laden) and opioid-related images, 2) performs fully-automated EEG signal processing and cue reactivity quantification, and 3) generates a digital report of opioid cue reactivity phenotypes which can be measured longitudinally to objectively quantify treatment endpoints (e.g., craving reduction, change in drug cue reactivity). Specific aims: There are two aims of this SBIR Phase I project, including: 1) measurement and longitudinal tracking of craving and EEG cue reactivity phenotypes in treatment-seeking OUD patients over 48 weeks of recovery, and 2) development of our NeuromarkR prototype into a scalable web platform for generating clinical insights and reports at the point of care. Expected outcome: Successful project outcomes include: 1) identification of drug cue reactivity phenotypes (e.g., EEG reactivity to opioid cues that resembles EEG reactivity to naturally rewarding cues) in OUD patients that correlate with recovery outcomes (e.g., treatment completion, prolonged abstinence, reduced craving), and 2) an established web platform that enables broader clinical and research use. Finally, we will obtain feedback from crucial stakeholders (e.g., clinicians, patients) and initiate Q-Submission meetings with the Food and Drug Administration to refine our regulatory plan for the Phase II project. Investigators: Our team includes experts in clinical substance abuse treatment, addiction neuroscience, EEG brain monitoring, software engineering, and health technology startup development expertise.