BACKGROUND Loss of control (LOC) is a pervasive feature of binge eating, which contributes significantly to the growing epidemic of obesity; approximately 80 million US adults are obese. Brain-responsive neurostimulation guided by the delta band was previously found to block binge-eating behavior in mice. Following novel preclinical work and a human case study demonstrating an association between the delta band and reward anticipation, the US Food and Drug Administration approved an Investigational Device Exemption for a first-in-human study. OBJECTIVE To assess feasibility, safety, and nonfutility of brain-responsive neurostimulation for LOC eating in treatment-refractory obesity. METHODS This is a single-site, early feasibility study with a randomized, single-blinded, staggered-onset design. Six subjects will undergo bilateral brain-responsive neurostimulation of the nucleus accumbens for LOC eating using the RNS® System (NeuroPace Inc). Eligible participants must have treatment-refractory obesity with body mass index ≥ 45 kg/m2. Electrophysiological signals of LOC will be characterized using real-time recording capabilities coupled with synchronized video monitoring. Effects on other eating disorder pathology, mood, neuropsychological profile, metabolic syndrome, and nutrition will also be assessed. EXPECTED OUTCOMES Safety/feasibility of brain-responsive neurostimulation of the nucleus accumbens will be examined. The primary success criterion is a decrease of ≥1 LOC eating episode/week based on a 28-d average in ≥50% of subjects after 6 mo of responsive neurostimulation. DISCUSSION This study is the first to use brain-responsive neurostimulation for obesity; this approach represents a paradigm shift for intractable mental health disorders.

中文翻译：

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大脑反应性神经刺激治疗饮食失控：早期可行性研究


背景失控（LOC）是暴食症的一个普遍特征，它在很大程度上导致了肥胖症的流行。大约有 8000 万美国成年人肥胖。先前发现由δ带引导的大脑反应性神经刺激可以阻止小鼠的暴食行为。在新颖的临床前工作和人体案例研究证明 delta 带与奖励预期之间存在关联之后，美国食品和药物管理局批准了一项首次人体研究的研究设备豁免。目的 评估脑反应性神经刺激用于治疗难治性肥胖的 LOC 饮食的可行性、安全性和有效性。方法 这是一项单中心、早期可行性研究，采用随机、单盲、交错开始设计。六名受试者将使用 RNS® 系统 (NeuroPace Inc) 接受双侧伏核的大脑反应性神经刺激，以进行 LOC 进食。符合资格的参与者必须患有难治性肥胖，体重指数≥45 kg/m2。 LOC 的电生理信号将使用实时记录功能和同步视频监控来表征。还将评估对其他饮食失调病理、情绪、神经心理学特征、代谢综合征和营养的影响。预期结果 将检查伏核脑反应性神经刺激的安全性/可行性。主要成功标准是根据 6 个月的反应性神经刺激后 50% 的受试者的 28 天平均值，每周减少 ≥1 LOC 饮食次数。讨论 这项研究是第一个使用大脑反应性神经刺激治疗肥胖的研究。这种方法代表了治疗顽固性精神健康疾病的范式转变。