Post-trial Access, Clinical Care, Psychosocial Support, and Scientific Progress in Experimental Deep Brain Stimulation Research

实验性深部脑刺激研究的试验后访问、临床护理、社会心理支持和科学进展

• 批准号: 10722437
• 负责人: Joseph J. Fins
• 金额: $ 54.27万
• 依托单位: HARVARD MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-18 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10722437
• 关键词: Academic Medical Centers; Address; Administrative Personnel; Articulation; Attitude; BRAIN initiative; Caring; Clinical; Consciousness Disorders; Data; Data Collection; Deep Brain Stimulation; Delphi Technique; Devices; Disease; Distress; Ecosystem; Ensure; Follow-Up Studies; Future; Gilles de la Tourette syndrome; Goals; Health Insurance; Impairment; Implant; Insurance; Insurance Coverage; Intervention; Intervention Trial; Interview; Investments; Learning; Life; Maintenance; Manufacturer; Maps; Mediation; Mental Depression; Mental disorders; Movement Disorders; Neurosciences; Obsessive-Compulsive Disorder; Participant; Personal Satisfaction; Persons; Physicians; Play; Policies; Privatization; Process; Provider; Psychosocial Assessment and Care; Recurrence; Research; Research Personnel; Resistance; Role; Stroke; Surveys; System; Technology Transfer; Therapeutic; Traumatic Brain Injury; Traumatic Brain Injury recovery; Withdrawal; clinical care; cost; design; expectation; experience; follow-up; gain of function; implantable device; improved; loss of function; meetings; neural; neural implant; neurotechnology; psychosocial; reduce symptoms; success; virtual

Project Summary Public and private research funders have heavily invested in the application of implantable neurotechnologies to improve the management of treatment-resistant conditions and loss of function (e.g., deep brain stimulation (DBS) systems for recovery after traumatic brain injury (TBI), stroke, disorders of consciousness, movement disorders, and psychiatric disorders such as obsessive-compulsive disorder (OCD) and depression). These devices are trialed with people who have had severe impairments and treatment-resistant disorders for many years. However, even when some participants show significant symptom relief or gain of function in these trials, there is no way to systematically ensure post-trial access to beneficial non-FDA approved investigational therapeutic devices. Loss of access or maintenance of promising neural interventions can cause recurrent severe, treatment-resistant conditions and distress related to loss of access and the financial difficulties associated with the costs necessary to support and maintain these devices generally without insurance coverage. Importantly, the end of the trial is just the beginning of a long readjustment process to life with these implanted neural devices for participants and care partners. They must renegotiate life roles and expectations and learn to navigate the world anew with the benefits, demands, and consequences of these emerging neurotechnologies. The goal of this research is to promote participant well-being and advance neuroscience by gaining a deeper understanding of participants and their care partners’ trajectory following DBS trials (e.g., experience with device access and maintenance, clinical care after the trial, psychosocial support needs to adjust to a life with the device), while maximizing opportunities for discovery following neural device trials. The aims of this study are (Aim 1) to examine the perspectives of post-trial participants and care partners from a diversity of DBS trials regarding their device, clinical, and psychosocial needs. To do this, we will conduct in-depth interviews with former participants in experimental DBS trials (e.g., TBI, OCD, depression, and Tourette syndrome (TS)), their care partners, and their local physicians. Interviews will examine their views, needs, and experiences regarding post-trial device access, clinical care for the DBS indication, adjustment to life post-trial, what kind of psychosocial support they believe could be helpful, and their attitudes about follow up studies. We will then (Aim 2) conduct in-depth interviews to examine the perspectives of researchers, device manufacturers, health insurance providers, and key administrative personnel (i.e., representatives of academic medical centers, FDA, and public and private research sponsors) regarding barriers and opportunities for post-trial device access, clinical care, psychosocial support, and the scientific implications of extended device access and longitudinal follow up. Finally, (Aim 3) we will use a modified policy Delphi technique to generate partnerships amongst the stakeholders to articulate the most pressing challenges and promising solutions to improve post-trial device access, clinical care, psychosocial support needs, and follow up data collection.

项目摘要 公共和私人研究资助者在植入式神经技术的应用上投入了大量资金 改善对耐药情况和功能丧失的管理(例如，脑深部刺激 (DBS)创伤性脑损伤、中风、意识障碍、运动后的康复系统 精神障碍，如强迫症(OCD)和抑郁症。这些 这些设备是在患有严重损伤和许多人的治疗抵抗力障碍的人身上进行试验的 好几年了。然而，即使一些参与者在这些试验中表现出显著的症状缓解或功能改善， 没有办法系统地确保试验后获得有益的非FDA批准的研究 治疗设备。失去或维持有希望的神经干预可能会导致复发 与失去通道和经济困难有关的严重的、抗拒治疗的情况和痛苦 与支持和维护这些设备所需的成本相关，通常没有保险 覆盖范围。重要的是，试验的结束只是长期重新适应这些生活的开始 为参与者和护理伙伴植入神经设备。他们必须重新协商生活角色和期望 并学会用这些新兴事物的好处、需求和后果重新驾驭世界 神经科技。这项研究的目标是促进参与者的幸福感，并通过以下方式促进神经科学 更深入地了解参与者及其护理伙伴在DBS试验后的轨迹(例如， 在设备访问和维护方面的经验，试验后的临床护理，心理支持需要调整 与该设备一起生活)，同时最大限度地增加在神经设备试验后发现的机会。的目标是 本研究的目的是(1)从不同的角度考察试验后参与者和护理伙伴的观点 关于他们的设备、临床和心理社会需求的DBS试验。为此，我们将进行深入的采访。 与曾参与实验性DBS试验(例如，脑外伤、强迫症、抑郁症和多发性抽动症(TS))的人一起， 他们的护理伙伴和他们的当地医生。访谈将考察他们的观点、需求和经历 关于试验后器械的使用，临床护理对于DBS的适应症，试验后的生活调整，什么样的 他们认为心理社会支持可能会有所帮助，以及他们对后续研究的态度。然后我们将(瞄准 2)进行深入访谈，考察研究人员、设备制造商、健康 保险提供商和主要管理人员(即学术医疗中心、FDA、 以及公共和私人研究赞助商)关于试验后设备访问的障碍和机会， 临床护理、心理社会支持，以及扩展设备访问和纵向访问的科学意义 继续跟进。最后，(目标3)我们将使用修改后的策略Delphi技术在 利益相关者阐明最紧迫的挑战和有希望的解决方案，以改进试验后设备 获取、临床护理、心理社会支持需求和后续数据收集。