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: 6680031
• 负责人: PATRICIA L FARIS
• 金额: $ 13.8万
• 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/6680031
• 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应用中，我们建议研究通过植入神经细胞假体（NCP）系统对10名严重治疗，抗药性耐药性蜂窝状神经性神经疾病的避免行为的安全性和功效。目前的治疗效果令人失望，在5年随访时仍有20％至50％的患者仍有症状。长期疾病的持续时间和高呕吐频率与预后最差有关。多种证据融合以表明异常的迷走神经传递可能在驱动粗暴行为方面起因作用。在此应用中，我们建议将植入的NCP系统用作迷走神经起搏器将提供对迷走神经活动的控制，从而增加实现总戒酒的患者数量。此外，我们建议在整个临床试验中对这些患者进行功能迷走神经活动的纵向测量。我们获得了FDA IDE和IRB批准来进行这项研究。拟议的研究将构成NCP首次用于治疗饮食失调症，特别是神经性贪食症。如果这项初步的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，那么将有必要进行更大的多中心研究。即将到来的迷走神经功能生理变化的结果将为刺激参数，生理变化和症状改善之间的关系提供初步见解。总的来说，这项研究中收集的数据可能会导致对严重，耐药性贪食症的病理生理学的增强和新颖的见解的发展。