Implanted Vagus Nerve Stimulators for Severe Bulimia

植入迷走神经刺激器治疗严重贪食症

• 批准号: 6779173
• 负责人: PATRICIA L FARIS
• 金额: $ 13.89万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-08-01 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6779173
• 关键词: behavior therapy; bulimia nervosa; clinical research; electronic pacemaker; electronic stimulator; electrophysiology; female; human subject; human therapy evaluation; implant; longitudinal human study; medical implant science; nervous system prosthesis; neurophysiology; patient oriented research; vagus nerve; women' s health

DESCRIPTION (provided by applicant): In this R03 application, we propose to study the safety and efficacy of vagal nerve stimulation (VNS) delivered through implantation of the NeuroCybemetic Prosthesis (NCP) System on bulimic behaviors in 10 female patients with severe, treatment-resistant bulimia nervosa. Current treatments have disappointing efficacies with 20 percent to 50 percent of patients still symptomatic at 5 year follow-up. A long illness duration and high frequencies of vomiting are associated with the poorest prognosis. Multiple lines of evidence converge to suggest that abnormal vagal neurotransmission may play a causative role in driving the bulimic behaviors. In this application, we propose that the use of the implanted NCP system as a vagal nerve pacemaker will provide enhanced control over vagal activity and thereby increase the number of patients achieving total abstinence. Additionally, we propose to conduct longitudinal measures of functional vagal activity in these patients across the clinical trial. We have obtained a FDA IDE and IRB approval to conduct this study. The proposed study would constitute the first use of the NCP for treatment of an eating disorder, specifically bulimia nervosa. If this initial pilot study finds this intervention to be both safe and effective in this small sample, then a larger, multicenter study would be warranted. The forthcoming results on physiological changes in vagal function will provide preliminary insights into the relationship between stimulation parameters, physiological changes, and symptom improvement. Collectively, the data collected during this study may lead to both the development of an enhanced treatment and novel insights into the pathophysiology of severe, treatment-resistant bulimia.

描述（由申请人提供）： 在此 R03 申请中，我们拟研究通过植入神经控制假体 (NCP) 系统进行迷走神经刺激 (VNS) 对 10 名患有严重难治性神经性贪食症女性患者的暴食行为的安全性和有效性。目前的治疗效果令人失望，20% 至 50% 的患者在 5 年随访时仍有症状。病程长和呕吐频率高与最差的预后有关。多种证据集中表明，异常的迷走神经传递可能在驱动暴食行为中发挥着因果作用。在此应用中，我们建议使用植入的 NCP 系统作为迷走神经起搏器将增强对迷走神经活动的控制，从而增加实现完全戒断的患者数量。此外，我们建议在整个临床试验中对这些患者的功能性迷走神经活动进行纵向测量。我们已获得 FDA IDE 和 IRB 批准开展这项研究。拟议的研究将首次使用 NCP 来治疗饮食失调，特别是神经性贪食症。如果这项初步试点研究发现这种干预措施在这个小样本中既安全又有效，那么就需要进行更大规模的多中心研究。即将公布的迷走神经功能生理变化结果将为刺激参数、生理变化和症状改善之间的关系提供初步见解。总的来说，这项研究期间收集的数据可能会导致增强治疗的发展，并对严重难治性贪食症的病理生理学产生新的见解。