Responsive Neurostimulation for Loss of Control Eating

项目摘要 背景/描述。鉴于我们对直接脑刺激的共同兴趣是一种有效的 治疗与顽固性肥胖相关的非依从性饮食障碍，我们的 斯坦福大学的多学科团队与NeuroPace公司建立了合作关系， 一家最近获得FDA批准的反应性神经刺激剂的公司。我们之前 研究发现，电刺激小鼠伏隔核(NAC)可减弱狂欢样行为 吃东西。此外，低频振荡中增加的功率似乎与时间相关 对食物奖励的预期，并预测狂欢的开始。越来越多的人意识到 肥胖的人经常会失去对食物的控制，这会导致暴饮暴食。我们 假设反应性神经刺激器可以用来识别低频 代表对进食失去控制的振荡，并向 NAC，以防止狂欢。目标。测试刺激参数和检测算法 早期可行性研究中的人类反应性神经刺激。方法：研究方法。所需的一切 将寻求监管途径，并将在人体内进行早期可行性研究 因饮食失控而导致顽固性肥胖的受试者。我们将主要评估设备 功能和安全性，但将利用多式联运控制和移动措施来测试 这一临床方案在肥胖患者进食低脂食物方面的潜力。

Project Abstract Background/Description. Given our mutual interest in direct brain stimulation as an effective treatment for non-adherent eating disorders associated with refractory obesity, our multidisciplinary team at Stanford University has developed a collaboration with NeuroPace, Inc, a company that recently received FDA approval for a responsive neurostimulator. We previously found that electrically stimulating the nucleus accumbens (NAc) of mice attenuates binge-like eating. In addition, increased power in low frequency oscillations appears to temporally correlate with anticipation of food reward and predict the onset of a binge. There is increasing awareness that obese individuals frequently lose control over food, which leads to binge-like eating. We hypothesize that a responsive neurostimulator could be used to identify low frequency oscillations that represent loss of control over eating and deliver responsive stimulation to the NAc to prevent a binge. Objective. To test stimulation parameters and detection algorithms for responsive neurostimulation in humans in an Early Feasibility Study. Methods. All needed regulatory avenues will be pursued, and an Early Feasibility Study will be performed in human subjects with refractory obesity due to loss of control eating. We will primarily assess device function and safety, but will utilize multimodal controlled and ambulatory measures to test the potential of this clinical program for LOC eating in obesity.