Joseph J Fins, Megan S Wright, Kaiulani S Shulman, Jaimie M Henderson, Nicholas D Schiff
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引用次数: 0
Abstract
This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study's success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives.
这是由两部分组成的系列论文中的第二篇,从CENTURY-S(CENtral Thalamic Deep Brain Stimulation for Treatmatic Brain InjURY Safety)的角度描述了受试者和家庭的观点,该研究首次在人类侵入性神经装置试验中实现了中重度创伤性脑损伤(msTBI)的认知恢复。为了参与,对受试者进行了独立评估,以正式建立提供自愿知情同意的决策能力。在这里,我们报道了丘脑刺激试验成功后进行的术后访谈。所有五名msTBI受试者都达到了预先选择的主要终点,即在Trail Making Test Part B中完成时间至少提高了10%,这是执行功能的标志。我们描述了受试者和家庭成员对这一成功的叙述反应。手术和刺激试验后的采访揭示了适应认知功能和情绪调节改善以及关系和家庭动态改变(和恢复)的挑战。这些改善暴露了重返社会的障碍,而康复曾经被认为是不可思议的。这项研究的成功引发了人们对试验后植入设备的使用、设备维护、电池更换和持续护理的担忧。大多数受试者和家庭都认为需要支持性咨询来适应他们生活的新轨迹。
期刊介绍:
The Cambridge Quarterly of Healthcare Ethics is designed to address the challenges of biology, medicine and healthcare and to meet the needs of professionals serving on healthcare ethics committees in hospitals, nursing homes, hospices and rehabilitation centres. The aim of the journal is to serve as the international forum for the wide range of serious and urgent issues faced by members of healthcare ethics committees, physicians, nurses, social workers, clergy, lawyers and community representatives.