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已经在应用可植入神经技术的应用上投入了大量投资 改善治疗疾病的管理和功能丧失（例如，深脑刺激 （DBS）创伤性脑损伤（TBI），中风，意识障碍，运动后恢复的系统 疾病和精神疾病，例如强迫症（OCD）和抑郁症）。这些 设备对许多人进行严重损害和耐药性疾病的人进行试用 年。但是，即使某些参与者在这些试验中表现出明显的症状缓解或功能增长， 无法系统地确保在审判后访问有益的非FDA批准的研究 治疗设备。失去诺言神经干预的访问或维护可能会导致反复发生 严重的，防治状况和与访问丧失和财务困难有关的困扰 与一般没有保险的情况下支持和维护这些设备所需的成本相关 覆盖范围。重要的是，审判的结束只是与这些生命的长期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 并学会以这些新兴的好处，需求和后果重新浏览世界 神经技术。这项研究的目的是促进参与者的福祉，并通过 在DBS试验之后，对参与者及其护理伙伴的轨迹有了更深入的了解（例如 具有设备访问和维护，试验后的临床护理经验，心理社会支持需要调整 通过设备的生活），同时在神经设备试验之后最大程度地发现发现机会。目的 这项研究是（目的1）检查后审判参与者和护理伙伴的观点。 关于其设备，临床和社会心理需求的DBS试验。为此，我们将进行深入的访谈 与实验DBS试验的前参与者（例如TBI，OCD，抑郁症和Tourette综合征（TS））， 他们的护理伙伴和当地医生。访谈将检查他们的观点，需求和经验 关于审判后的设备访问，DBS适应症的临床护理，对审判后的生活调整，什么样的 他们认为会有所帮助的社会心理支持，并且他们参加后续学习。然后我们将（目标 2）进行深入的访谈以检查研究人员，设备制造商，健康的观点 保险提供者和主要行政人员（即代表FDA的学术医疗中心， 以及公共和私人研究赞助商）有关障碍和审判设备访问机会的机会， 临床护理，社会心理支持以及扩展设备访问和纵向的科学意义 跟进。最后，（目标3）我们将使用修改的政策Delphi技术来建立合作伙伴关系 利益相关者阐明最紧迫的挑战和承诺解决方案以改善后审判设备 访问，临床护理，社会心理支持需求和跟进数据收集。