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: 10264121
• 负责人: Scott Burwell
• 金额: $ 11.49万
• 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 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10264121
• 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; detection platform; 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; underserved area; 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.

项目概要/摘要 意义：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 OUD 干预措施中哪些内容“有效”（哪些无效）。 目前，还没有标准化、客观的护理工具来告知治疗提供者患者的病情 阿片类药物的渴求程度和复发易感性，使得治疗效果主观且不清楚 减少渴望并防止复发。这些不足导致了代价高昂且长期的循环 复发、急诊室就诊、法律问题、重新入院治疗、用药过量和可能的死亡 OUD 患者所经历的。创新：使用消费级移动脑电图 (EEG) 耳机和专有软件，Neurotype Inc. 提议开发和商业化 NeuromarkR™，一个护理点大脑传感平台，能够检测脑电图提示反应性相关性 药物渴望以及药物使用和复发的前瞻性指标。 NeuromarkR 可用于 EEG 非 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性、基准治疗 有效性，并可能为治疗决策提供信息。 NeuromarkR平台：1）获取患者的脑电图 在查看情感（充满情绪）和阿片类药物相关图像期间，2) 执行全自动脑电图信号 处理和提示反应性量化，以及 3) 生成阿片类提示反应性的数字报告 可以纵向测量的表型，以客观地量化治疗终点（例如，渴望 减少，药物提示反应性的变化）。具体目标：SBIR 第一阶段项目有两个目标， 包括：1）测量和纵向追踪渴望和脑电图提示反应表型 寻求治疗的 OUD 患者恢复超过 48 周，以及 2) 开发我们的 NeuromarkR 原型 进入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。预期的 结果：成功的项目成果包括：1）药物提示反应表型的识别（例如脑电图） OUD 患者对阿片类药物线索的反应类似于脑电图对自然奖励线索的反应） 与恢复结果相关（例如治疗完成、延长禁欲时间、减少渴望），以及 2) 一个成熟的网络平台，可实现更广泛的临床和研究用途。最后我们会得到反馈 来自关键利益相关者（例如临床医生、患者）的意见，并与食品和药物管理局发起 Q-提交会议 政府将完善二期项目的监管计划。调查人员：我们的团队包括专家 临床药物滥用治疗、成瘾神经科学、脑电图脑监测、软件工程、 和健康技术初创公司开发专业知识。