Responsive Neurostimulation for Loss of Control Eating

项目摘要 背景/说明。考虑到我们对直接脑刺激的共同兴趣， 治疗与难治性肥胖相关的非依从性进食障碍，我们 斯坦福大学的一个多学科团队与NeuroPace公司合作， 一家最近获得FDA批准的反应神经刺激器公司。我们之前 研究发现，电刺激小鼠的延髓核（NAc）可以减弱类似暴食的 吃此外，低频振荡中功率的增加似乎与 与食物奖励的预期并预测暴食的开始。人们越来越认识 肥胖的人经常会失去对食物的控制，从而导致暴饮暴食。我们 假设响应神经刺激器可用于识别低频 振荡代表对进食的失去控制，并将响应性刺激传递给 为了防止暴饮暴食。Objective.测试刺激参数和检测算法， 在早期可行性研究中对人类进行神经刺激。方法.所有需要的 将寻求监管途径，并将在人类中进行早期可行性研究。 由于饮食失控而患有难治性肥胖的受试者。我们将主要评估器械 功能和安全性，但将利用多模式控制和流动措施，以测试 这一临床项目对肥胖症患者的减肥潜力。

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.