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

用于检测阿片类药物渴望和治疗反应的移动大脑传感平台

• 批准号: 10158211
• 负责人: Scott Burwell
• 金额: $ 23.51万
• 依托单位: NEUROTYPE INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10158211
• 关键词: Abstinence; Affective; American; Assessment tool; Benchmarking; Biological Markers; Brain; Cessation of life; Chronic; Classification; Clinical; Clinical Research; Clinical Trials; Clinical assessments; Computer software; Cues; Data; Detection; Development; Drug usage; Electroencephalogram; Emergency department visit; Emotions; Erotica; Feedback; Food; Funding; Future; Goals; Health; Health Insurance Portability and Accountability Act; Health Personnel; Health Technology; Image; Industry; Intervention; Laboratories; Legal; Legal patent; Letters; Literature; Measurement; Measures; Medical Device; Monitor; National Institute of Drug Abuse; Neurosciences; Opioid; Outcome; Overdose; Palate; Patients; Pharmaceutical Preparations; Phase; Phenotype; Physiological Processes; Process; Provider; Recovery; Regulatory Pathway; Relapse; Reporting; Research; Research Personnel; Retreatment; Rewards; Science; Seeds; Severities; Small Business Innovation Research Grant; Software Engineering; Source; Standardization; Substance Use Disorder; Tablets; Technology; Time; Translating; Treatment Effectiveness; United States Food and Drug Administration; United States National Institutes of Health; Work; addiction; base; care providers; clinically relevant; commercialization; cost; craving; cue reactivity; design; digital; drug craving; drug relapse; experience; improved; innovation; insight; meetings; novel therapeutics; opioid use; opioid use disorder; point of care; population based; portability; prospective; prototype; relapse prediction; response; sensor technology; signal processing; substance abuse treatment; tool; treatment response; web platform

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.

项目摘要/摘要 意义：超过200万美国人患有阿片类药物使用障碍（OUD）和继电器治疗后接力 超过60％的人，强调了OUD干预中的“有效”（以及无效）的需求。 目前，尚无标准化的客观护理工具来为患者的治疗提供者提供通知 阿片类药物渴望和中继脆弱性的水平，使治疗的有效性使主观和不清楚 减少渴望和防止救济。这种不足有助于昂贵和慢性周期 退休，急诊室访问，法律问题，治疗重新服用，服用过量和可能的死亡 由Oud患者体验。创新：使用消费级移动脑电图（EEG） 耳机和专有软件，Neurotype Inc.提案开发和商业化 Neuromarkr™，一个护理点脑感应平台，可检测EEG提示反应性相关性 药物渴望和药物使用和救济的预期指标。脑电图可能会使用神经元。 专家（例如临床医生，技术人员）量化阿片类药物渴望的生物标志物相关，基准治疗 有效性，并有可能为治疗决定提供信息。 Neuromarkr平台：1）获取患者的脑电图 在观看情感（情感）和阿片类药物相关图像时，2）执行完全自动的脑电图信号 处理和提示反应性量化，以及3）生成阿片类药物提示反应性的数字报告 可以纵向测量以量化治疗终点的表型（例如渴望 减少，药物提示反应性的变化）。具体目的：这个SBIR I期项目有两个目标， 包括：1）渴望和脑电图反应性表型的测量和纵向跟踪 在48周恢复48周内寻求治疗的OUD患者，以及2）我们的神经原型的发展 进入一个可扩展的网络平台，以在护理点生成临床见解和报告。预期的 结果：成功的项目结果包括：1）鉴定药物提示反应性表型（例如，脑电图 对OUD患者的脑电图反应性的反应性，类似于脑电图反应性自然奖励提示） 与恢复结果相关（例如，治疗完成，延长节制，渴望减少）和2） 建立的网络平台，可实现更广泛的临床和研究用途。最后，我们将获得反馈 来自关键的利益相关者（例如临床医生，患者），并与食品和药物启动Q-submission会议 管理我们针对II期项目的监管计划。调查人员：我们的团队包括专家 在临床药物滥用治疗中，成瘾神经科学，脑电图大脑监测，软件工程， 和卫生技术创业发展专业知识。