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， 改善对治疗抵抗性病症和功能丧失的管理（例如，脑深部电刺激 (DBS)创伤性脑损伤（TBI）、中风、意识障碍、运动后恢复系统 疾病和精神疾病如强迫症（OCD）和抑郁症）。这些 这些设备在患有严重损伤和治疗抵抗性疾病的人身上进行了试验， 年然而，即使一些参与者在这些试验中表现出明显的症状缓解或功能获得， 没有办法系统地确保试验后获得有益的非FDA批准的研究药物， 治疗设备失去进入或维持有希望的神经干预可能会导致复发性 严重的、难以治疗的疾病以及与无法进入和经济困难有关的痛苦 与支持和维护这些设备所需的成本相关，通常没有保险 覆盖重要的是，审判的结束只是一个漫长的重新调整过程的开始， 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 并学会利用这些新兴事物的好处、需求和后果重新驾驭世界 神经技术这项研究的目标是通过以下方式促进参与者的幸福感和推进神经科学 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， 器械使用和维护经验、试验后的临床护理、心理社会支持需要调整 与设备的生活），同时最大限度地提高神经设备试验后的发现机会。的目的 本研究（目的1）从不同的角度研究试验后参与者和护理伙伴的观点， DBS试验涉及其器械、临床和心理社会需求。为此，我们将进行深入采访 与实验性DBS试验的前参与者（例如，TBI、OCD、抑郁症和抽动秽语综合征（TS））， 他们的护理伙伴和当地的医生。访谈将考察他们的观点、需求和经验 关于试验后器械使用、DBS适应症的临床护理、试验后生活调整、 他们认为有帮助的心理支持，以及他们对后续研究的态度。我们将（Aim） 2)进行深入访谈，以研究人员，设备制造商，健康 保险供应商，和关键行政人员（即，学术医疗中心的代表，FDA， 以及公共和私人研究申办者）关于试验后器械获取的障碍和机会， 临床护理、心理社会支持以及延长器械使用和纵向 跟进最后，（目标3）我们将使用修改后的政策德尔菲技术，在 利益相关者阐明最紧迫的挑战和有希望的解决方案，以改善试验后器械 访问、临床护理、心理社会支持需求和后续数据收集。