Exploring the Attitudes, Barriers, Concerns, Differences, and Ethics (ABCDEs) of Healthcare Decision Making in Prospective Peripheral Indications for Vagus Nerve Stimulation Patients

探索迷走神经刺激患者预期外周适应症中医疗决策的态度、障碍、担忧、差异和道德 (ABCDE)

• 批准号: 10789644
• 负责人: Lynn E Eberly
• 金额: $ 6.08万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10789644
• 关键词: Address; Adoption; Adult; Affect; Anatomy; Attitude; Award; Brain; Cardiovascular system; Caregivers; Catalogs; Central Nervous System; Cervical; Chest wall structure; Clinical; Complement; Cranial Nerves; Craniotomy; Data; Data Set; Decision Making; Deep Brain Stimulation; Development; Devices; Disease; Electric Stimulation; Electroconvulsive Therapy; Electrodes; Eligibility Determination; Enrollment; Epilepsy; Ethical Issues; Ethics; Evaluation; Focus Groups; Funding; Gatekeeping; Health Care Ethics; Healthcare; Heart failure; Human; Immune; Immune System Diseases; Immunologics; Implant; Individual; Interview; Intractable Epilepsy; Knowledge; Medical; Mental Depression; Metabolic; Metabolic Diseases; Methods; Motor; Neurologic; Neurologist; Neurosurgeon; Newly Diagnosed; Operative Surgical Procedures; Organ; Parents; Participant; Patient Recruitments; Patients; Perception; Peripheral; Pharmaceutical Preparations; Phase; Physicians; Physiologic pulse; Population; Population Sizes; Process; Psychiatrist; Public Health; Recommendation; Research; Risk; Series; Site; Standardization; Structure; Survey Methodology; System; Technology; Transcranial magnetic stimulation; United States Food and Drug Administration; United States National Institutes of Health; Vagus nerve structure; Work; barrier to care; behavioral health; cranium; depressed patient; design; implantable device; implantation; insight; neuroregulation; physical conditioning; programs; prospective; recruit; response; social stigma; treatment comparison; treatment response; uptake; vagus nerve stimulation

The NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC-V) initiative will primarily focus on cervical vagus nerve stimulation (VNS). Despite VNS achieving its first Food and Drug Administration (FDA) clearance in 2001 in drug resistant epilepsy and a second indication in difficult to treat depression in 2005, VNS has made minimal public health impacts. Over 125,000 individuals are utilizing clinical VNS. This relatively low uptake in proportion to the size of the population eligible for VNS suggests patients perceive VNS poorly or have unaddressed ethical concerns regarding this technology. VNS is a unique form of invasive neuromodulation requiring a VNS therapy pulse generator to be surgically implanted in the chest wall and a tunneled electrode that delivers intermittent electrical stimulation to the vagus nerve. VNS differs from other forms of electrical neuromodulation uniquely in its invasiveness. Compared to electroconvulsive therapy (ECT) and deep brain stimulation (DBS) in that it indirectly affects the brain through a cranial nerve rather than cortical stimulation so it does not require craniotomy like the latter. Additionally, adequate VNS therapy response is delayed compared to other forms of electrical neuromodulation with ECT inducing response in the order of 1 mo and DBS inducing motor response as early as the same day of device activation. The protracted response trajectory generates ethical issues in neuromodulation particular to this technology deserving of further consideration in order to understand VNS healthcare decision making. REVEAL/SPARC-V offers a unique opportunity to observe a large population anticipating implantation with VNS. The study will recruit adults seeking VNS therapy for both epilepsy and difficult to treat depression and observe them after implantation to characterize VNS’s effects on peripheral systems such as the cardiovascular, immunologic or metabolic systems in addition to their clinical response. These patients offer a unique opportunity to characterize previously unexamined ethical issues and perceptions of VNS while the technology is poised to be developed for additional peripheral indications. We propose a mixed-methods evaluation to characterize VNS specific ethical factors that can impact VNS acceptability for its current indications and to proactively assess these factors for emerging indications in peripheral disease states. After a series of development focus groups a semi structured interview phase assess VNS ethical considerations in depression, epilepsy and prospective peripheral indications in groups of physicians, patients and their caregivers and perform thematic analysis. Additionally, we will use survey methods to assess perceptions of stigma, acceptability, risks,benefits,invasiveness, and barriers to care (defined as medical decision metrics). This work will crucially contribute to the under-examined ethics of VNS. Our proposal will set the stage for better adoption of VNS for both central nervous system illnesses and peripheral organ diseases.

美国国立卫生研究院刺激外周活动缓解条件（SPARC-V）倡议将主要集中